Assisted Reproductive TechniquesPhase 3PERSISTNCT01297465
PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
A Phase 3 study testing Gonal-f®, Pergoveris® and Recombinant human chorionic gonadotropin (r-hCG) in people with Assisted Reproductive Techniques and Reproductive Technology, Assisted, run by Merck KGaA, Darmstadt, Germany at 23 sites in 11 countries.
Trial summary
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. Read more about this study
- Who is it for?
- Ages 36 to 40 years, women only
- Conditions the study is for
- Assisted Reproductive Techniques, Reproductive Technology, Assisted
- What is being tested?
- Gonal-f®, Pergoveris® and Recombinant human chorionic gonadotropin (r-hCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 23 sitesin 11 countries
- Study dates
- 31 May 2011to 31 Oct 2012
- 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 36 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment
- Be between her 36th and 40th birthday (both included) at the time of the randomization visit
- Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (=<)12 IU/L) measured in the center's local laboratory during the screening period (that is within 2 months prior to down-regulation start)
- A body mass index (BMI) less than (<) 30 kilogram per square meter (kg/m^2)
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- Be willing and able to comply with the protocol for the duration of the trial
Show all 9Show fewer
- Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
- Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
- Other protocol specified inclusion criteria could also apply.
Who cannot join
- Had >= 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as =< 6 mature follicles and/or =<4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as >= 25 oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's medical responsible
- Had previous severe ovarian Hyperstimulation Syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- Any contraindication to being pregnant and/or carrying a pregnancy to term
- History of 3 or more miscarriages (early or late miscarriages) due to any cause
Show all 13Show fewer
- A clinically significant systemic disease
- Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner
- Known allergy or hypersensitivity to human gonadotrophin preparations
- Entered previously into this trial or simultaneous participation in another clinical trial.
- Pregnancy and lactation period
- Participation in another clinical trial within the past 30 days
- Other protocol specified inclusion criteria could also apply.
Trial locations and contacts
23 sites in 11 countries.
23 sites in 11 countries
France5 sites
Research Site
Bondy
Research Site
Bruges
Research Site
Clamart
Research Site
Thenon
Research Site
Villeurbanne
Greece3 sites
Research Site
Athens
Research Site
Heraklion, Crete
Research Site
Pylaia, Thessaloniki
About this study
Official title: A Phase IIIB, Multicentre, Multinational, Randomized, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® Day 1 to Day 5 Followed by Pergoveris® Starting Day 6 to Pergoveris® Starting Day 1 in Women Between 36 and 40 Years of Age Undergoing Assisted Reproductive Technique (ART)
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:
- GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
- Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Read more
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).
- Being tested
- Gonal-f®, Pergoveris®, Recombinant human chorionic gonadotropin (r-hCG)
- Keywords
- Ovulation Induction, Ovarian Stimulation, Reproductive Technique, Assisted, Assisted Reproductive Technics, Assisted Reproductive Technique, Reproductive Technology, Assisted
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-f®Drug
Also called Follitropin alfa
Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).
Pergoveris®Drug
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
Pergoveris®Drug
Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
Recombinant human chorionic gonadotropin (r-hCG)Drug
Also called Ovidrel®, Ovitrelle®
250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles >= 18 mm).
| Study group | Role | What they receive |
|---|---|---|
| Gonal-f® Plus Pergoveris® | Active comparator | Not described Receives: Drug: Gonal-f®; Drug: Pergoveris®; Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| Pergoveris® | Experimental | Not described Receives: Drug: Pergoveris®; Drug: Recombinant human chorionic gonadotropin (r-hCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Number of Oocytes Retrieved
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
Measured: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])
Secondary outcomes (13)
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Measured: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])
Total Number of Stimulation Treatment Days
Measured: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])
Implantation Rate
Implantation rate per reporting group was measured as the number of fetal sacs observed, divided by the number of embryos transferred multiplied by 100.
Measured: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Fetal Sacs With Activity
Number of fetal sacs with activity was evaluated by ultrasound scan
Measured: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])
Number of Fetal Hearts With Activity
Number of fetal hearts with activity was evaluated by ultrasound scan
Measured: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])
Clinical Pregnancy Rate
Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy. Clinical pregnancy rate was reported as total clinical pregnancy rate, clinical pregnancy rate per cycle started and per embryo transfer [ET]).
Measured: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
An excessive ovarian response: greater than or equal to 25 oocytes which could put the participant at risk of OHSS; An insufficient ovarian response: defined as 3 or less follicles of greater than or equal to 12 millimeter developing following at least 7 days of treatment.
Measured: S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Biochemical Pregnancies Rate
Biochemical pregnancy was defined as the pregnancy diagnosed only by the detection of human chorionic gonadotropin (hCG) in serum or urine and that does not develop into a clinical pregnancy. Participants with beta- hCG concentration greater than 10 international units per liter (IU/L) were considered as biochemical pregnant.
Measured: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Multiple Pregnancies
Multiple pregnancy was defined as the existence of more than one fetal sac with fetal heart activity.
Measured: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
Ovarian Hyper Stimulation Syndrome (OHSS) is a syndrome which can manifest with enlarged ovaries, advanced ascites with increased vascular permeability, pleural fluid accumulation, hemoconcentration, and increased blood clotting. Early OHSS was defined as the onset of OHSS occurring within 9 days after oocyte retrieval and late OHSS was defined as the onset of OHSS occurring on or after day 10 from oocyte retrieval.
Measured: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Treatment-emergent Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Measured: Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Systolic and Diastolic Arterial Blood Pressure Assessments
Measured: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Heart Rate Assessments
Measured: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study start31 May 2011
- Primary completion31 Oct 2012
- Study completion31 Oct 2012
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 (2)Papers the sponsor has linked to this study.
- Other trials for Assisted Reproductive TechniquesStudies 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
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A., Geneva, Merck A/S, Denmark, Merck OY, Finland, Merck Serono S.A.S, France, Merck Serono GmbH, Germany, Merck A.E., Greece, Merck B.V., Netherlands, Merck SP. Z.O.O., Poland, Merck Serono S.P.A., Italy, Merck Services U.K. Ltd, UK, LLC Merck, Russia, Merck spol. s r.o., Slovakia, Merck Pharma, K.S., Slovakia
- Responsible party
- Sponsor
- Investigators
- Salvatore Longobardi, MD, Study director, Merck Serono S.P.A., Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297465
- Sponsor's protocol ID
- EMR 200061-504
- Other IDs
- 2010-023534-23
- Acronym
- PERSIST
- Status last verified
- May 2021
- First submitted
- 15 Feb 2011
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
H Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)
Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15.
PubMed 26194884
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Multicentre, Multinational, Randomized, Open-label Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® Day 1 to Day 5 Followed by Pergoveris® Starting Day 6 to Pergoveris® Starting Day 1 in Women Between 36 and 40 Years of Age Undergoing Assisted Reproductive Technique (ART)
- ClinicalTrials.gov ID
- NCT01297465
- Acronym / sponsor ID
- PERSIST / EMR 200061-504
- Keywords
- Ovulation Induction, Ovarian Stimulation, Reproductive Technique, Assisted, Assisted Reproductive Technics, Assisted Reproductive Technique, Reproductive Technology, Assisted
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A., Geneva, Merck A/S, Denmark, Merck OY, Finland, Merck Serono S.A.S, France, Merck Serono GmbH, Germany, Merck A.E., Greece, Merck B.V., Netherlands, Merck SP. Z.O.O., Poland, Merck Serono S.P.A., Italy, Merck Services U.K. Ltd, UK, LLC Merck, Russia, Merck spol. s r.o., Slovakia, Merck Pharma, K.S., Slovakia
- Study start
- 31 May 2011 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Oct 2012 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle. Down-regulation treatment will start within 2 months following the screening visit. The routine long luteal phase protocol for gonadotropin-releasing hormone (GnRH) agonist treatment will be followed. Once down-regulation has been confirmed, a pregnancy test will be performed just before randomization and start of recombinant human follicle-stimulating hormone (r-hFSH) treatment to rule out any pre-existing pregnancy. If the result is negative, the subject will be randomly assigned to one of the two treatment arms of the trial:
- GONAL-f®: (Liquid Pen; 300 international unit [IU] of per day) stimulation Day 1-5 followed by Pergoveris® (vial/powder, 300 IU per day) from stimulation Day 6 and until required recombinant human chorionic hormone (r-hCG) criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
- Pergoveris®: (vial/powder, 300 IU per day) from stimulation Day 1 and until required r-hCG criterion is met. The dose can be adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
Randomization across the two treatment arms will be kept balanced in a 1:1 ratio. Follicular development will be monitored according to the center's standard practice by ultrasound (US) and/or estradiol (E2) levels, until the protocol r-hCG requirement is met (i.e., at least one follicle greater than or equal to [>=] 18 millimeter [mm] and two follicles >=16 mm). After this, a single injection of r-hCG will be administered in order to induce final oocyte maturation.
At a time of 34-38 hours after r-hCG administration, oocytes will be recovered vaginally under US monitoring. Oocytes will then be fertilized in vitro and embryos replaced 2-5 days after oocyte recovery. Ovum pick up (OPU), in vitro fertilization (IVF), embryo transfer (ET) and luteal support will be performed as per center's standard practice.
A post-treatment safety visit will be performed for all subjects who received r-hCG (pregnant and non- pregnant) on Day 15-20 post-hCG. For subjects who have withdrawn from treatment (i.e. after starting Pergoveris® or Gonal-f® but before hCG is given) this visit will take place 20-30 days after their first Pergoveris® or Gonal-f® treatment injection (excluding pregnancy testing).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gonal-f® Plus Pergoveris® | Active comparator | Drug: Gonal-f®, Drug: Pergoveris®, Drug: Recombinant human chorionic gonadotropin (r-hCG) |
| Pergoveris® | Experimental | Drug: Pergoveris®, Drug: Recombinant human chorionic gonadotropin (r-hCG) |
Who may qualify
- Ages
- 36 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Be a female subject justifying an in vitro fertilization and embryo transfer (IVF/ET) treatment
- Be between her 36th and 40th birthday (both included) at the time of the randomization visit
- Have early follicular phase (Day 2-4) serum level of basal follicle stimulating hormone (FSH less than or equal to (=<)12 IU/L) measured in the center's local laboratory during the screening period (that is within 2 months prior to down-regulation start)
- A body mass index (BMI) less than (<) 30 kilogram per square meter (kg/m^2)
- Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
Key exclusion criteria (13 listed)
- Had >= 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as =< 6 mature follicles and/or =<4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as >= 25 oocytes retrieved
- Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Merck Serono's medical responsible
- Had previous severe ovarian Hyperstimulation Syndrome (OHSS)
- Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- Any contraindication to being pregnant and/or carrying a pregnancy to term
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 |
|---|---|---|
| Gonal-f®Also: Follitropin alfaGonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5). | Drug | Gonal-f® Plus Pergoveris® |
| Pergoveris®Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice. | Drug | Gonal-f® Plus Pergoveris® |
| Pergoveris®Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice. | Drug | Pergoveris® |
| Recombinant human chorionic gonadotropin (r-hCG)Also: Ovidrel®, Ovitrelle®250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles >= 18 mm). | Drug | Gonal-f® Plus Pergoveris®, Pergoveris® |
Primary outcome
Total Number of Oocytes Retrieved
Time frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])
The total number of oocytes retrieved per reporting group on the day of ovum pick-up (OPU) (34-38 hours post r-hCG day) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization (IVF) in order to remove oocytes from the ovary of the female participant, enabling fertilization outside the body.
13 secondary outcomes
Total Dose and Mean Daily Dose of Follicle Stimulating Hormone (FSH)
Time frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])
Total Number of Stimulation Treatment Days
Time frame: Day 1 up to r-hCG day (end of stimulation cycle [approximately 11 days])
Implantation Rate
Time frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Fetal Sacs With Activity
Time frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])
Number of Fetal Hearts With Activity
Time frame: Days 35-42 post r-hCG day [end of stimulation cycle {approximately 11 days}])
Clinical Pregnancy Rate
Time frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Cancelled Cycles Due to Excessive or Insufficient Ovarian Response to Treatment
Time frame: S1 until Day 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Biochemical Pregnancies Rate
Time frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Multiple Pregnancies
Time frame: Days 35-42 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Early and Late Ovarian Hyper Stimulation Syndrome (OHSS)
Time frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Number of Participants With Treatment-emergent Adverse Events
Time frame: Day 1 up to days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Systolic and Diastolic Arterial Blood Pressure Assessments
Time frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Heart Rate Assessments
Time frame: Days 15-20 post r-hCG day (end of stimulation cycle [approximately 11 days])
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationH Behre, C Howles, S Longobardi. Luteinizing hormone supplementation from Day 1 versus 6 of ovarian stimulation in women aged 36-40 years: results from an open-label, randomized, multicentre, multinational trial. Human Reproduction. 2013;28(suppl 1)
- Results publication: PubMed 26194884Behre HM, Howles CM, Longobardi S; PERSIST Study Investigators. Randomized trial comparing luteinizing hormone supplementation timing strategies in older women undergoing ovarian stimulation. Reprod Biomed Online. 2015 Sep;31(3):339-46. doi: 10.1016/j.rbmo.2015.06.002. Epub 2015 Jun 15.
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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.
Salvatore Longobardi, MD study director
Merck Serono S.P.A., Italy
23 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gonal-f®, Pergoveris® and Recombinant human chorionic gonadotropin (r-hCG) in people with Assisted Reproductive Techniques and Reproductive Technology, Assisted, run by Merck KGaA, Darmstadt, Germany at 23 sites in 11 countries.
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 9 inclusion and 13 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France, Greece, Italy, Denmark, Germany and 6 more countries. 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 Feb 2014). 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?
Total Number of Oocytes Retrieved (time frame: OPU day (34-38 hours post r-hCG day [end of stimulation cycle {approximately 11 days}])). 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 NCT01297465, which also lists 2 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 28 May 2021.