InfertilityPhase 3NCT03228680
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
A Phase 3 study testing Follitropin delta and Follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 17 sites in Japan.
Trial summary
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Follitropin delta and Follitropin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 17 sitesJapan
- Study dates
- 29 Jul 2017to 8 Jul 2019
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed Consent Documents signed prior to any trial-related procedures.
- In good physical and mental health.
- Japanese females between the ages of 20 and 40 years.
- Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine (ASRM) classification) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) treatment using ejaculated sperm from male partner.
- Infertility for at least 1 year before randomization (not applicable in case of tubal or severe male factor infertility).
- The trial cycle will be the participant's first controlled ovarian stimulation cycle for IVF/ICSI.
Show all 10Show fewer
- Hysterosalpingography, hysteroscopy, saline infusion sonography or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to screening. This also includes women who have been diagnosed with any of the above medical conditions but have had them surgically corrected within 1 year prior to screening.
- Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and fallopian tubes and surrounding tissue without evidence of significant abnormality (e.g. no hydrosalpinx) within 1 year prior to screening. Both ovaries must be accessible for oocyte retrieval.
- Early follicular phase (cycle day 2-4) serum levels of follicle stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to screening).
- Body mass index (BMI) between 17.5 and 32.0 kg/m^2 (both inclusive) at screening.
Who cannot join
- Known endometriosis stage III-IV (defined by the revised ASRM classification).
- One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to start of stimulation on stimulation day 1 (puncture of cysts prior randomization is allowed).
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy).
- Known abnormal karyotype of participant or of her partner. In case the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y chromosome microdeletion, must be documented.
- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
- Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease.
- Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Akita University Hospital
Akita
Yachiyo Hospital
Anjo, Aichi-ken
Investigational Site 8121
Chiba, Chiba
Investigational Site 8123
Higashiōsaka-shi, Osaka
Yamashita Ladies' Clinic
Hyōgo
Yokota Maternity Hospital
Maebashi, Gunma
Investigational Site 8120
Osaka, Osaka
Ladies Clinic Kitahama
Osaka, Osaka
Sophia Ladies Clinic
Sagamihara, Kanagawa
Investigational Site 8126
Saitama
Omiya Ladies Clinic
Saitama
Saint Women's Clinic
Saitama
Women's Clinic Fujimino
Saitama
Investigational Site 8125
Saitama-shi, Saitama
Investigational Site 8122
Sendai, Miyagi
Investigational Site 8124
Shinjuku-Ku, Tokyo
Tokushima University Hospital
Tokushima
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
- Conditions
- Infertility
- Being tested
- Follitropin delta, Follitropin beta
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin deltaDrug
Also called FE 999049, REKOVELLE
Single daily subcutaneous administration through pre-filled injection pen
Follitropin betaDrug
Also called FOLLISTIM
Single daily subcutaneous injection in the abdomen
| Study group | Role | What they receive |
|---|---|---|
| Follitropin delta | Experimental | FE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. Receives: Drug: Follitropin delta |
| Follitropin beta | Active comparator | FOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. Receives: Drug: Follitropin beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
Measured: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)
Secondary outcomes (38)
Clinical Pregnancy Rate
Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.
Measured: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate
Defined as positive serum beta-hCG test 13-15 days after transfer.
Measured: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
Vital Pregnancy Rate
Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer.
Measured: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Implantation Rate
Implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by the number of blastocysts transferred.
Measured: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response
Measured: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk
Measured: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Defined as proportion of participants grouped according to the number of oocytes retrieved. The proportion of participants with <4 oocytes (low response), 4-7 oocytes (moderate response), 8-14 oocytes (targeted response), 15-19 oocytes (hyperresponse) and ≥20 oocytes (severe hyperresponse) are presented.
Measured: On the day of oocyte retrieval (up to 22 days after start of stimulation)
Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
Measured: On the day of oocyte retrieval (up to 22 days after start of stimulation)
Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
Measured: ≤9 days after triggering of final follicular maturation
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Defined as proportion of participants with early OHSS, early OHSS of moderate or severe grade, preventive interventions for early OHSS, early OHSS and/or preventive interventions for early OHSS, and early OHSS of moderate or severe grade and/or preventive interventions for early OHSS are presented.
Measured: Up to 9 days after triggering of final follicular maturation
Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)
Defined as proportions of participants with late OHSS (including OHSS of moderate/severe grade).
Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The proportion of participants with late OHSS, and late OHSS of moderate or severe grade are presented. All OHSS cases were graded as mild, moderate, or severe.
Measured: >9 days after triggering of final follicular maturation
Number of Follicles on Stimulation Day 6
Defined as the number of follicles observed in both ovaries at the last transvaginal ultrasound (TVUS) in the stimulation phase (on stimulation Day 6).
Measured: At Day 6 of stimulation
Number of Follicles at End-of-stimulation
Defined as the number of follicles observed in both ovaries at the last TVUS in the stimulation phase (end-of-stimulation).
Measured: End-of-stimulation (up to 20 stimulation days)
Size of Follicles on Stimulation Day 6
Defined as size characteristics of follicles on stimulation Day 6.
Average size of 3 largest follicles has been presented in this endpoint.
Measured: At Day 6 of stimulation
Size of Follicles at End-of-Stimulation
Defined as size characteristics of follicles at end-of-stimulation.
Average size of 3 largest follicles has been presented in this endpoint.
Measured: End-of-stimulation (up to 20 stimulation days)
Fertilization Rate
The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved.
Measured: Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)
Number and Quality of Embryos
Number of embryos (total and good-quality) on Day 3 are presented. A good-quality embryo was defined as an embryo with ≥6 blastomeres and fragmentation ≤20% on Day 3.
Measured: Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)
Number and Quality of Blastocysts
Number of embryos (total and good-quality) on Day 5 are presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
Measured: Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6
The median and inter-quartile range (IQR) of FSH and LH levels on stimulation Day 6 are presented.
Measured: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation
The median and IQR of FSH and LH levels at end-of-stimulation are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6
The median and IQR of estradiol levels on stimulation Day 6 are presented.
Measured: At Day 6 of stimulation
Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation
The median and IQR of estradiol levels at end-of-stimulation are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6
The median and IQR of progesterone levels on stimulation Day 6 are presented.
Measured: At Day 6 of stimulation
Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation
The median and IQR of progesterone levels at end-of-stimulation are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6
The median and IQR of Inhibin A levels on stimulation Day 6 are presented.
Measured: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation
The median and IQR of Inhibin A levels at end-of-stimulation are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6
The median and IQR of inhibin B levels on stimulation Day 6 are presented.
Measured: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation
The median and IQR of inhibin B levels at end-of-stimulation are presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Number of Stimulation Days
Measured: End-of-stimulation (up to 20 stimulation days)
Total Gonadotropin Dose of FE 999049
Measured: End-of-stimulation (up to 20 stimulation days)
Total Gonadotropin Dose of FOLLISTIM
Measured: End-of-stimulation (up to 20 stimulation days)
Number of Participants With Adverse Events (AEs) Stratified by Intensity
The frequency of participants with total AEs and AEs by categories of intensity (mild, moderate, severe) are presented. An AE was any untoward medical occurrence in a participants participating in clinical trial. The intensity of 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); or severe = inability to work or perform usual activities (unacceptable).
Measured: From signed informed consent up to 5-6 weeks after transfer
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation
Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
Measured: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation
Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
Measured: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial
Defined as number of participants with at least one markedly abnormal finding in clinical chemistry parameters (as assessed by investigator) were reported. The clinical chemistry parameters included: alanine transaminase (ALT), albumin, alkaline phosphatase (ALP), aspartate aminotransferase (AST), bicarbonate, bilirubin direct, bilirubin total, blood urea nitrogen, calcium, chloride, cholesterol total, creatinine, gamma-glutamyl transpeptidase, glucose, lactate dehydrogenase, phosphorus, potassium, sodium, total protein, uric acid.
Measured: Up to 5-6 weeks after transfer
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
Defined as number of participants with at least one markedly abnormal changes in hematology parameters (as assessed by investigator) were reported. Hematology parameters included: red blood cells, white blood cells, red blood cells morphology, white blood cells morphology, haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, platelets.
Measured: Up to 5-6 weeks after transfer
Frequency and Intensity of Injection Site Reactions
The presence of of injection site reactions (redness, itching, pain, swelling and bruising) immediately, 30 minutes and 24 hours after the injection are presented. The injection site reactions were assessed as none, mild, moderate and severe. The number of injection site reactions (mild, moderate or severe) based on all assessments performed is presented.
Measured: End-of-stimulation (up to 20 stimulation days)
Technical Malfunctions of the Administration Pens
Measured: End-of-stimulation (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 posted25 Jul 2017
- Study start29 Jul 2017
- Primary completion10 Jun 2019
- Study completion8 Jul 2019
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 373 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
- NCT03228680
- Sponsor's protocol ID
- 000273
- Status last verified
- Apr 2021
- First submitted
- 13 Jul 2017
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ishihara O, Arce JC; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-918. doi: 10.1016/j.rbmo.2021.01.023. Epub 2021 Feb 9.
PubMed 33722477Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
PubMed 34799275Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.
PubMed 37156263
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Assessing the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women Undergoing an Assisted Reproductive Technology Programme
- ClinicalTrials.gov ID
- NCT03228680
- Acronym / sponsor ID
- 000273
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 8 Jul 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 24 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follitropin delta | Experimental | Drug: Follitropin deltaFE 999049 was administered as single daily subcutaneous injections in the abdomen. Participants randomized to FE 999049 had their individual dose determined on the basis of their anti-Müllerian hormone (AMH) level at screening and their body weight at randomization. The daily FE 999049 dose was fixed throughout the stimulation period. The minimum allowed daily FE 999049 dose was 6 μg and maximum allowed daily dose was 12 μg. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
| Follitropin beta | Active comparator | Drug: Follitropin betaFOLLISTIM was administered as single daily subcutaneous injections in the abdomen. The starting dose of FOLLISTIM was 150 IU and fixed for the first five stimulation days, after which it could be adjusted by 75 IU based on the individual response. The maximum allowed daily dose was 375 IU. Dosing continued until the criterion for triggering of final follicular maturation was met. Participants could be treated for a maximum of 20 days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Informed Consent Documents signed prior to any trial-related procedures.
- In good physical and mental health.
- Japanese females between the ages of 20 and 40 years.
- Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II (defined by the revised American Society for Reproductive Medicine (ASRM) classification) or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) treatment using ejaculated sperm from male partner.
- Infertility for at least 1 year before randomization (not applicable in case of tubal or severe male factor infertility).
Key exclusion criteria (8 listed)
- Known endometriosis stage III-IV (defined by the revised ASRM classification).
- One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to start of stimulation on stimulation day 1 (puncture of cysts prior randomization is allowed).
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy).
- Known abnormal karyotype of participant or of her partner. In case the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y chromosome microdeletion, must be documented.
- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
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 |
|---|---|---|
| Follitropin deltaAlso: FE 999049, REKOVELLESingle daily subcutaneous administration through pre-filled injection pen | Drug | Follitropin delta |
| Follitropin betaAlso: FOLLISTIMSingle daily subcutaneous injection in the abdomen | Drug | Follitropin beta |
Primary outcome
Number of Oocytes Retrieved
Time frame: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
38 secondary outcomes
Clinical Pregnancy Rate
Time frame: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Positive Beta Unit of Human Chorionic Gonadotropin (Beta-hCG) Rate
Time frame: 13-15 days after transfer (up to approximately 1.5 months after start of stimulation)
Vital Pregnancy Rate
Time frame: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Implantation Rate
Time frame: 5-6 weeks after transfer (up to approximately 3 months after start of stimulation)
Proportion of Participants With Cycle Cancellation Due to Poor or Excessive Ovarian Response
Time frame: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants With Blastocyst Transfer Cancellation Due to Excessive Ovarian Response / OHSS Risk
Time frame: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved
Time frame: On the day of oocyte retrieval (up to 22 days after start of stimulation)
Proportion of Participants With Extreme Ovarian Responses (Defined as <4, ≥15 or ≥20 Oocytes Retrieved) in Risk Population
Time frame: On the day of oocyte retrieval (up to 22 days after start of stimulation)
Proportion of Participants With Preventive Interventions for Early Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: ≤9 days after triggering of final follicular maturation
Proportions of Participants With Early OHSS (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS
Time frame: Up to 9 days after triggering of final follicular maturation
Proportions of Participants With Late OHSS (Including OHSS of Moderate/Severe Grade)
Time frame: >9 days after triggering of final follicular maturation
Number of Follicles on Stimulation Day 6
Time frame: At Day 6 of stimulation
Number of Follicles at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Size of Follicles on Stimulation Day 6
Time frame: At Day 6 of stimulation
Size of Follicles at End-of-Stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Fertilization Rate
Time frame: Day 1 after oocyte retrieval (up to approximately 22 days after start of stimulation)
Number and Quality of Embryos
Time frame: Day 3 after oocyte retrieval (up to approximately 24 days after start of stimulation)
Number and Quality of Blastocysts
Time frame: Day 5 after oocyte retrieval (up to approximately 26 days after start of stimulation)
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) on Stimulation Day 6
Time frame: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Follicle-stimulating Hormone [FSH], Luteinising Hormone [LH]) at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameter (Estradiol) on Stimulation Day 6
Time frame: At Day 6 of stimulation
Circulating Levels of Endocrine Parameter (Estradiol) at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameter (Progesterone) on Stimulation Day 6
Time frame: At Day 6 of stimulation
Circulating Levels of Endocrine Parameter (Progesterone) at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameters (Inhibin A) on Stimulation Day 6
Time frame: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Inhibin A) at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Circulating Levels of Endocrine Parameters (Inhibin B) on Stimulation Day 6
Time frame: At Day 6 of stimulation
Circulating Levels of Endocrine Parameters (Inhibin B) at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Number of Stimulation Days
Time frame: End-of-stimulation (up to 20 stimulation days)
Total Gonadotropin Dose of FE 999049
Time frame: End-of-stimulation (up to 20 stimulation days)
Total Gonadotropin Dose of FOLLISTIM
Time frame: End-of-stimulation (up to 20 stimulation days)
Number of Participants With Adverse Events (AEs) Stratified by Intensity
Time frame: From signed informed consent up to 5-6 weeks after transfer
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-stimulation
Time frame: End-of-stimulation (up to 20 stimulation days)
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Clinical Chemistry Parameters at End-of-trial
Time frame: Up to 5-6 weeks after transfer
Proportion of Participants Who Had Markedly Abnormal Value Changes From Baseline in Hematology Parameters at End-of-trial
Time frame: Up to 5-6 weeks after transfer
Frequency and Intensity of Injection Site Reactions
Time frame: End-of-stimulation (up to 20 stimulation days)
Technical Malfunctions of the Administration Pens
Time frame: End-of-stimulation (up to 20 stimulation days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33722477Ishihara O, Arce JC; Japanese Follitropin Delta Phase 3 Trial (STORK) Group. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-918. doi: 10.1016/j.rbmo.2021.01.023. Epub 2021 Feb 9.
- Results publication: PubMed 34799275Ishihara O, Nelson SM, Arce JC. Comparison of ovarian response to follitropin delta in Japanese and White IVF/ICSI patients. Reprod Biomed Online. 2022 Jan;44(1):177-184. doi: 10.1016/j.rbmo.2021.09.014. Epub 2021 Sep 23.
- Results publication: PubMed 37156263Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.
- 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
17 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 Follitropin delta and Follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 17 sites in Japan.
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 8 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Japan. 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 24 Mar 2021). 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 Oocytes Retrieved (time frame: 36h (± 2h) after triggering of final follicular maturation (On day of oocyte retrieval)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228680, which also lists 3 linked publications.
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 24 Aug 2023.