InfertilityPhase 3CLARANCT04163458
Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
A Phase 3 study testing MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL and MENOPUR powder and solvent for solution for injection, 75 IU in people with Infertility, run by Ferring Pharmaceuticals at 20 sites in United States.
Trial summary
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL and MENOPUR powder and solvent for solution for injection, 75 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 405 participants
- Where
- 20 sitesUnited States
- Study dates
- 25 Oct 2019to 16 Jul 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consents, prior to any trial-related procedure.
- Females between the ages of 18 and 42 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 43rd birthday) at the time of randomization who desire pregnancy.
- Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.
- Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.
- Documented history of infertility for at least 12 months before randomization for women ≤35 years or for at least 6 months for women ≥36 years. Women with documented bilateral tubal occlusion or male factor infertility requiring the use of donor sperm established as a cause of infertility are eligible at diagnosis.
- Early follicular phase (cycle day 2-4) serum FSH level between 1 and 12 IU/L (results obtained within 3 months prior to randomization).
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- Male partner with semen analysis that is at least adequate for intracytoplasmic sperm injection (ICSI) at screening or within 6 months prior to the screening date. Partners with severe male factors requiring invasive or surgical sperm retrieval may not be used. Use of donor sperm is allowed.
- At least 1 cycle with no fertility medication immediately prior to screening.
- Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine anatomy appropriate for ART at screening or within 12 months prior to screening.
- Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of clinically significant abnormality (e.g., endometrioma ≥3 cm, no dermoid cysts) and normal adnexa (e.g., no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.
Who cannot join
- More than two previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/ICSI
- Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
- Oocyte donor or embryo recipient; gestational or surrogate carrier.
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
- Participant's male partner, with obvious leukospermia (>2 million white blood cells/mL) or signs of infection in semen sample within 6 months of the participant's screening. If either of these conditions exists, the male should be treated with antibiotics and retested prior to the participant's randomization.
- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
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- Any known endocrine (total testosterone, prolactin and TSH) or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
- Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotrophins.
- Any abnormal finding of clinical chemistry, hematology and vital signs at screening, which is judged clinically significant by the investigator.
- Pregnancy (negative urine pregnancy test must be documented at screening and prior to the first investigational medicinal product [IMP] administration), or contraindication to pregnancy.
- Hypersensitivity to any active ingredient or excipients in the medicinal products used in this trial.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Abington Reproductive Medicine
Abington, Pennsylvania, 19046
Fertility Answers, LLC
Baton Rouge, Louisiana, 70817
Center for Assisted Reproduction
Bedford, Texas, 76022
Idaho Center for Reproductive Medicine
Boise, Idaho, 83702
Reproductive Endocrinology Associates of Charlotte
Charlotte, North Carolina, 28207
Fertility Centers of Illinois
Chicago, Illinois, 60610
Institute for Reproductive Health
Cincinnati, Ohio, 45209
Center for Advanced Reproductive Services PC
Farmington, Connecticut, 06032
InVia Fertility Specialists, SC
Hoffman Estates, Illinois, 60169
Houston Fertility Institute
Houston, Texas, 77063
SIRM Fertility Center
Las Vegas, Nevada, 89118
Fertility Associates of Memphis, PLLC
Memphis, Tennessee, 38120
Fertility and IVF Center of Miami
Miami, Florida, 33176
Yale Fertility Center
New Haven, Connecticut, 06511
OU Physicians Reproductive Medicine
Oklahoma City, Oklahoma, 73104
Carolina Conceptions
Raleigh, North Carolina, 27607
Fertility Specialists Medical Group - San Diego Center for Reproductive Surgery
San Diego, California, 92123
Fertility Treatment Center
Tempe, Arizona, 85284
Center of Reproductive Medicine
Webster, Texas, 77598
Center for Reproductive Medicine
Winter Park, Florida, 32789
About this study
Official title: A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
- Conditions
- Infertility
- Being tested
- MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL, MENOPUR powder and solvent for solution for injection, 75 IU, Placebo (for MENOPUR solution for injection in pre-filled pen), Placebo (for MENOPUR powder and solvent for solution for injection)
- Keywords
- Controlled Ovarian Stimulation, Assisted Reproductive Technology
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mLDrug
Also called Highly purified menotropin
Solution for injection in pre-filled pen, subcutaneous administration
MENOPUR powder and solvent for solution for injection, 75 IUDrug
Also called Highly purified menotropin
Solution for injection in vials (powder and diluent), subcutaneous administration
Placebo (for MENOPUR solution for injection in pre-filled pen)Other
Solution for injection in pre-filled pen, subcutaneous administration
Placebo (for MENOPUR powder and solvent for solution for injection)Other
Solution for injection in vials (powder and diluent); subcutaneous administration
| Study group | Role | What they receive |
|---|---|---|
| MENOPUR liquid | Experimental | MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. Receives: Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL; Other: Placebo (for MENOPUR powder and solvent for solution for injection) |
| MENOPUR powder | Active comparator | MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. Receives: Drug: MENOPUR powder and solvent for solution for injection, 75 IU; Other: Placebo (for MENOPUR solution for injection in pre-filled pen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Fertilized (2 Pronuclei [2PN]) Oocytes
Fertilized oocytes with 2PN were regarded as correctly fertilized.
Measured: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Secondary outcomes (53)
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
A blood serum βhCG test was obtained 10-14 days after blastocyst transfer. If the test was positive according to the local laboratory's reference ranges, this confirmed a positive βhCG.
Measured: 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)
Clinical Pregnancy Rate
Clinical pregnancy was based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound.
Measured: 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)
Ongoing Pregnancy Rate
Ongoing pregnancy was based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound
Measured: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)
Early Pregnancy Loss
Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy.
Measured: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)
Follicular Development on Stimulation Day 6
The total number of follicles and the number of follicles per size category were reported.
Measured: At stimulation Day 6
Follicular Development on Last Day of Stimulation
The total number of follicles and the number of follicles per size category were reported.
Measured: At last day of stimulation (up to 20 stimulation days)
Serum Follicle-stimulating Hormone (FSH) Concentration
The concentration of serum FSH was measured. The median and IQR of FSH levels on stimulation day 6, End of stimulation and Oocyte Retrieval visit are presented.
Measured: At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)
Serum Anti-Müllerian Hormone (AMH) Concentration
The concentration of serum AMH was measured. The median and IQR of AMH levels on End of stimulation and End of Trial are presented.
Measured: At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)
Human Chorionic Gonadotropin (hCG) Concentration
The concentration of hCG was measured. The median and IQR of hCG levels on stimulation day 6 and End of stimulation are presented.
Measured: At Day 6 and last day of stimulation (up to 20 stimulation days)
Luteinizing Hormone (LH) Concentration
The concentration of LH was measured. The median and IQR of LH levels on stimulation day 6 and End of stimulation are presented.
Measured: At Day 6 and last day of stimulation (up to 20 stimulation days)
Progesterone (P4) Concentration
The concentration of P4 was measured. The median and IQR of P4 levels on stimulation day 6 and End of stimulation are presented.
Measured: At Day 6 and last day of stimulation (up to 20 stimulation days)
Estradiol (E2) Concentration
The concentration of E2 was measured. The median and IQR of E2 levels on stimulation day 6 and End of stimulation are presented.
Measured: At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)
Number of Oocytes Retrieved
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Metaphase II (MII) Oocytes
Maturity stage was assessed prior to undergoing ICSI. Maturity stage was categorized as germinal vesicle, metaphase I, metaphase II, degenerated or other.
Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)
Fertilization Rate
Fertilization rate(%) is the number of 2PN oocytes divided by the number of oocytes retrieved.
Measured: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval
The number of blastocysts (total and good-quality) was reported. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)
Measured: On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)
Total Gonadotropin Dose
The gonadotropin starting dose was 225 IU for the first 5 days, followed by individual adjustments according to the participant's follicular response. Dose adjustment should be 75 IU per adjustment. Gonadotropin was to be initiated within 3 days of confirmed downregulation.
Measured: Up to 20 stimulation days
Number of Stimulation Days
Calculated by start dates and end dates.
Measured: Up to 20 stimulation days
Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
OHSS was defined as the total of early OHSS with onset ≤9 days after triggering of final follicular maturation, and late OHSS with onset >9 days after triggering of final follicular maturation.
Measured: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
Frequency of Adverse Events (AEs)
Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.
Measured: From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)
Intensity of AEs
The intensity of an AE was classified using the following 3-point scale: Mild = Awareness of signs or symptoms, but no disruption of usual activity. Moderate = Event sufficient to affect usual activity (disturbing). Severe = Inability to work or perform usual activities (unacceptable).
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American
Blood samples were collected for the analysis of clinical chemistry parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Eosinophils/Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Lymphocytes/Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Monocytes/Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Neutrophils/Leukocytes
Blood samples were collected for the analysis of haematology parameters.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Proportion of Subjects With Markedly Abnormal Changes of Clinical Parameters and Haematology Parameters
The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-trial visit values.
It is only parameters with markedly abnormal values at end of stimulation or end of trial visit which are represented. Parameters with normal baseline values and normal end of stimulation and end of trial values are not represented.
Measured: From the start of screening until the end-of-trial (up to approximately 6 months)
Frequency of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period
Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.
Total Number of events include all categories None, Mild, Moderate and Severe. Percentage of events with injection site reactions as a sum of the categories Mild, Moderate and Severe is presented.
Measured: Up to 20 stimulation days
Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Participant During the Stimulation Period
Assessed by the participant during the stimulation period as mild, moderate or severe.
Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.
Measured: Up to 20 stimulation days
Proportion of Participants With Treatment-induced Anti-MENOPUR Antibodies. Overall as Well as With Neutralizing Capacity
Measured by presence of anti-MENOPUR antibodies.
95% Clopper-Pearson confidence interval has been reported in this endpoint.
Measured: Up to 28 days after end of the stimulation period (simulation period up to 20 days)
Number of Participants With Potential Technical Malfunctions of the Administration Pen
Number of participants With Potential Technical malfunctions of the Administration Pen were recorded.
Measured: Up to 20 stimulation days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start25 Oct 2019
- Primary completion28 May 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163458
- Sponsor's protocol ID
- 000303
- Acronym
- CLARA
- Status last verified
- Aug 2023
- First submitted
- 28 Oct 2019
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program
- ClinicalTrials.gov ID
- NCT04163458
- Acronym / sponsor ID
- CLARA / 000303
- Conditions
- Infertility
- Keywords
- Controlled Ovarian Stimulation, Assisted Reproductive Technology
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MENOPUR liquid | Experimental | Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL, Other: Placebo (for MENOPUR powder and solvent for solution for injection)MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. |
| MENOPUR powder | Active comparator | Drug: MENOPUR powder and solvent for solution for injection, 75 IU, Other: Placebo (for MENOPUR solution for injection in pre-filled pen)MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Signed informed consents, prior to any trial-related procedure.
- Females between the ages of 18 and 42 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 43rd birthday) at the time of randomization who desire pregnancy.
- Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.
- Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.
- Documented history of infertility for at least 12 months before randomization for women ≤35 years or for at least 6 months for women ≥36 years. Women with documented bilateral tubal occlusion or male factor infertility requiring the use of donor sperm established as a cause of infertility are eligible at diagnosis.
Key exclusion criteria (11 listed)
- More than two previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/ICSI
- Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
- Oocyte donor or embryo recipient; gestational or surrogate carrier.
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
- Participant's male partner, with obvious leukospermia (>2 million white blood cells/mL) or signs of infection in semen sample within 6 months of the participant's screening. If either of these conditions exists, the male should be treated with antibiotics and retested prior to the participant's randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mLAlso: Highly purified menotropinSolution for injection in pre-filled pen, subcutaneous administration | Drug | MENOPUR liquid |
| MENOPUR powder and solvent for solution for injection, 75 IUAlso: Highly purified menotropinSolution for injection in vials (powder and diluent), subcutaneous administration | Drug | MENOPUR powder |
| Placebo (for MENOPUR solution for injection in pre-filled pen)Solution for injection in pre-filled pen, subcutaneous administration | Other | MENOPUR powder |
| Placebo (for MENOPUR powder and solvent for solution for injection)Solution for injection in vials (powder and diluent); subcutaneous administration | Other | MENOPUR liquid |
Primary outcome
Number of Fertilized (2 Pronuclei [2PN]) Oocytes
Time frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilized oocytes with 2PN were regarded as correctly fertilized.
53 secondary outcomes
Positive Beta Human Chorionic Gonadotropin (βhCG) Rate
Time frame: 10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)
Clinical Pregnancy Rate
Time frame: 5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)
Ongoing Pregnancy Rate
Time frame: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)
Early Pregnancy Loss
Time frame: 8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)
Follicular Development on Stimulation Day 6
Time frame: At stimulation Day 6
Follicular Development on Last Day of Stimulation
Time frame: At last day of stimulation (up to 20 stimulation days)
Serum Follicle-stimulating Hormone (FSH) Concentration
Time frame: At Day 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation)
Serum Anti-Müllerian Hormone (AMH) Concentration
Time frame: At the last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6 months from the start of screening)
Human Chorionic Gonadotropin (hCG) Concentration
Time frame: At Day 6 and last day of stimulation (up to 20 stimulation days)
Luteinizing Hormone (LH) Concentration
Time frame: At Day 6 and last day of stimulation (up to 20 stimulation days)
Progesterone (P4) Concentration
Time frame: At Day 6 and last day of stimulation (up to 20 stimulation days)
Estradiol (E2) Concentration
Time frame: At stimulation Day 6 and last day of stimulation (up to 20 stimulation days)
Number of Oocytes Retrieved
Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Metaphase II (MII) Oocytes
Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Fertilization Rate
Time frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Blastocysts and Number of Good-Quality Blastocysts 5 Days After Oocyte Retrieval
Time frame: On Day 5 after oocyte retrieval (up to 27 days after start of stimulation)
Total Gonadotropin Dose
Time frame: Up to 20 stimulation days
Number of Stimulation Days
Time frame: Up to 20 stimulation days
Proportion of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
Frequency of Adverse Events (AEs)
Time frame: From the time of signed informed consent for participation in the trial until the end-of-trial visit (up to approximately 6 months)
Intensity of AEs
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Alanine Aminotransferase
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Aspartate Aminotransferase
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Blood Urea Nitrogen
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Calcium
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Chloride
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Creatinine
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Gamma Glutamyl Transferase
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Glucose
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Potassium
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Sodium
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr African American
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Clinical Chemistry Parameters Compared to Baseline: Egfr Non-afr. American
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Erythrocytes
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Leukocytes
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hemoglobin
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Hematocrit
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Platelets
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Changes in Circulating Levels of Haematology Parameters Compared to Baseline: Basophils/Leukocytes
Time frame: From the start of screening until the end-of-trial (up to approximately 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL and MENOPUR powder and solvent for solution for injection, 75 IU in people with Infertility, run by Ferring Pharmaceuticals at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Fertilized (2 Pronuclei [2PN]) Oocytes (time frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.