A Phase 4 interventional study of Menotropin and Progestrone vaginal insert in Infertility, sponsored by Ferring Pharmaceuticals. Completed at 7 sites in United States. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2011-11-02.
Sponsored by Ferring Pharmaceuticals · Phase 4, Interventional, and Treatment
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 173 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Drug: Menotropin · Drug: Progestrone vaginal insert · Drug: Ganirelix
Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Drug: Menotropin · Drug: Progesterone in oil · Drug: Ganirelix
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Drug: Progestrone vaginal insert · Drug: follitropin beta · Drug: Ganirelix
Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.
Drug: follitropin beta · Drug: Progesterone in oil · Drug: Ganirelix
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
Also known as: highly purified menotropins, Menopur®, hMG
100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
Also known as: progesterone, Endometrin®
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
Also known as: Follistim Pen®, Follistim®
50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Also known as: ganirelix acetate, GnRH antagonist
Percentage of Participants With Ongoing Pregnancy at Week 8
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
Time frame: Week 8 (Week 6 of gestation)
Number of Follicles Observed at Day 15
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Time frame: Day 15
Number of Oocytes Retrieved at Day 18
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
Time frame: Approximately Day 18
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
Time frame: Approximately Day 19
Number of Embryos Transferred at Three Stages of Development
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
Time frame: Approximately Day 24
Number of Embryos Frozen at Day 24
The number of embryos that were not transferred but instead were frozen for future use.
Time frame: Approximately Day 24
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Time frame: Day 1 to Day 24
Participants With Biochemical Pregnancy at Day 38
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Time frame: approximately day 38 (Day 14 post embryo transfer)
Participants With Clinical Pregnancy at Week 7
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Time frame: approximately week 7
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
Time frame: Day 1 - week 12
Number of Live Births
Time frame: Approximately 10 months
One hundred ninety one (191) participants were screened from 6 study centers in the US; 173 of these participants were eligible for randomization. Six subjects did not receive their respected treatment and two subjects withdrew consent, 165 subjects were included in the statistical analyses
| Milestone | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Started | 42 | 42 | 42 | 39 |
| Completed | 18 | 16 | 17 | 17 |
| Not completed | 24 | 26 | 25 | 22 |
| Withdrew: Stimulation failure | 4 | 0 | 3 | 3 |
| Withdrew: Inadequate number of oocytes retrieved | 0 | 0 | 0 | 1 |
| Withdrew: Cycle cancelled | 0 | 1 | 1 | 1 |
| Withdrew: Risk of ovarian hyperstimulation syndrom | 0 | 0 | 0 | 1 |
| Withdrew: No positive serum pregnancy | 17 | 20 | 14 | 10 |
| Withdrew: Pregnancy not confirmed by ultrasound | 1 | 0 | 1 | 0 |
| Withdrew: Pregnancy loss/miscarriage | 0 | 2 | 0 | 3 |
| Withdrew: Other | 2 | 3 | 6 | 3 |
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
| follicles | Menopur | Follistim |
|---|---|---|
| Number of Follicles Observed at Day 15 | 15.6 ± 8.6 | 16.2 ± 8.4 |
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
| oocytes | Menopur | Follistim |
|---|---|---|
| Number of Oocytes Retrieved at Day 18 | 11.5 ± 6.3 | 13.8 ± 7.9 |
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
| proportion of oocytes retrieved | Menopur | Follistim |
|---|---|---|
| Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved | 0.3 ± 0.4 | 0.3 ± 0.4 |
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
| embryos | Menopur | Follistim |
|---|---|---|
| Number of Embryos transferred | 2.1 ± 0.7 | 2.4 ± 0.7 |
| Number of Morula transferred | 0.0 ± 0.1 | 0.1 ± 0.4 |
| Number of Blastocytes transferred | 0.9 ± 1 | 0.9 ± 1 |
The number of embryos that were not transferred but instead were frozen for future use.
| embryos | Menopur | Follistim |
|---|---|---|
| Number of Embryos Frozen at Day 24 | 1.9 ± 2.9 | 1.6 ± 2.5 |
A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
| participants | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle | 0 | 1 | 1 | 2 |
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
| percentage of participants | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Percentage of Participants With Ongoing Pregnancy at Week 8 | 45.2 | 45.2 | 42.9 | 48.7 |
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
| participants | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Participants With Biochemical Pregnancy at Day 38 | 21 | 20 | 22 | 23 |
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
| participants | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Participants With Clinical Pregnancy at Week 7 | 19 | 19 | 18 | 20 |
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale: mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable. Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
| participants | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| With at least one adverse event | 20 | 18 | 18 | 21 |
| Mild or moderate adverse event | 20 | 18 | 18 | 21 |
| Severe adverse event | 1 | 0 | 2 | 0 |
| Serious adverse event | 0 | 1 | 1 | 0 |
| Unrelated or unlikely adverse event | 15 | 13 | 17 | 14 |
| Possibly or probably related adverse event | 10 | 8 | 7 | 15 |
No measurements were reported for this outcome.
Collected over Treatment-emergent adverse events were collected from Day 1 to Week 12.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Menopur/Endometrin | — | 0/42 (0%) | 20/42 (47.6%) |
| Menopur/Progesterone in Oil | — | 1/42 (2.4%) | 18/42 (42.9%) |
| Follistim/Endometrin | — | 1/42 (2.4%) | 18/42 (42.9%) |
| Follistim/Progesterone in Oil | — | 0/39 (0%) | 21/39 (53.8%) |
| Event | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Ovarian hyperstimulation syndrome with ascitesReproductive system and breast disorders | 0/42 | 1/42 | 0/42 | 0/39 |
| Hyperemesis gravidarumGastrointestinal disorders | 0/42 | 0/42 | 1/42 | 0/39 |
| Event | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil |
|---|---|---|---|---|
| Adnexa uteri painReproductive system and breast disorders | 6/42 | 7/42 | 6/42 | 9/39 |
| NauseaGastrointestinal disorders | 3/42 | 5/42 | 3/42 | 8/39 |
| Ovarian hyperstimulation syndromeReproductive system and breast disorders | 3/42 | 1/42 | 1/42 | 8/39 |
| Abdominal distensionGastrointestinal disorders | 4/42 | 6/42 | 3/42 | 5/39 |
| Procedural painInjury, poisoning and procedural complications | 1/42 | 3/42 | 5/42 | 2/39 |
| Abdominal pain lowerGastrointestinal disorders | 3/42 | 0/42 | 0/42 | 0/39 |
| Abdominal pain upperGastrointestinal disorders | 1/42 | 0/42 | 0/42 | 2/39 |
| DizzinessNervous system disorders | 1/42 | 0/42 | 1/42 | 2/39 |
| Pelvic painReproductive system and breast disorders | 0/42 | 0/42 | 0/42 | 2/39 |
| Abdominal painGastrointestinal disorders | 0/42 | 0/42 | 2/42 | 0/39 |
| Age Continuous(years) | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil | Total |
|---|---|---|---|---|---|
| Mean | 33.5 ± 4.1 | 33.2 ± 4.8 | 34.0 ± 4.3 | 33.9 ± 4.3 | 33.9 ± 7.4 |
| Sex: Female, Male(Participants) | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil | Total |
|---|---|---|---|---|---|
| Female | 42 | 42 | 42 | 39 | 165 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil | Total |
|---|---|---|---|---|---|
| Caucasian | 32 | 35 | 31 | 32 | 130 |
| African American | 5 | 1 | 2 | 2 | 10 |
| Asian | 4 | 2 | 6 | 2 | 14 |
| Hispanic | 1 | 4 | 3 | 1 | 9 |
| Other | 0 | 0 | 0 | 2 | 2 |
| Body Mass Index (BMI)(kg/m^2) | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil | Total |
|---|---|---|---|---|---|
| Mean | 24.6 ± 4.1 | 23.8 ± 3.0 | 25.0 ± 3.3 | 25.6 ± 4.5 | 24.6 ± 3.8 |
| Follicle-stimulating hormone level(mIU/mL) | Menopur/Endometrin | Menopur/Progesterone in Oil | Follistim/Endometrin | Follistim/Progesterone in Oil | Total |
|---|---|---|---|---|---|
| Mean | 7.4 ± 2.3 | 7.1 ± 2.2 | 6.9 ± 2.0 | 6.9 ± 2.9 | 7.3 ± 2.3 |
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