- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802360
MENOPUR® Versus FOLLISTIM®
A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
Pasadena, California, United States, 91105
- Huntington Reproductive Center
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San Diego, California, United States, 92130
- San Diego Fertility Center
-
-
Colorado
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Littleton, Colorado, United States, 80129
- Conceptions Reproductive Associates of Colorado
-
-
Florida
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Clearwater, Florida, United States, 33759
- Women's Medical Research Group, LLC
-
-
Illinois
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Naperville, Illinois, United States, 60540
- The Advanced IVF Institute; Charles E. Miller, MD & Associates
-
-
Louisiana
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Baton Rouge, Louisiana, United States, 70815
- A Woman's Center for Reproductive Medicine
-
-
Texas
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Bedford, Texas, United States, 76022
- Center for Assisted Reproduction
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pre-menopausal females between the ages of 18 and 42 years
- Body mass index (BMI) of 18-34
- Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
- Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
- Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
- Signed informed consent
Exclusion Criteria:
- Gestational or surrogate carrier, donor oocyte
- Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
- Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles.
- History of recurrent pregnancy loss (>2).
- Presence of abnormal uterine bleeding of undetermined origin
- Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
- Participation in any experimental drug study within 30 days prior to Screening
- Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Menopur/Endometrin
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. |
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.
Other Names:
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.
Other Names:
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Other Names:
|
Experimental: Menopur/Progesterone in Oil
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. |
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.
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.
Other Names:
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Other Names:
|
Active Comparator: Follistim/Endometrin
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. |
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.
Other Names:
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
Other Names:
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.
Other Names:
|
Active Comparator: Follistim/Progesterone in Oil
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. |
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Ongoing Pregnancy at Week 8
Time Frame: Week 8 (Week 6 of gestation)
|
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.
|
Week 8 (Week 6 of gestation)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Follicles Observed at Day 15
Time Frame: Day 15
|
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
|
Day 15
|
Number of Oocytes Retrieved at Day 18
Time Frame: Approximately Day 18
|
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
|
Approximately Day 18
|
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
Time Frame: Approximately Day 19
|
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
|
Approximately Day 19
|
Number of Embryos Transferred at Three Stages of Development
Time Frame: Approximately Day 24
|
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
|
Approximately Day 24
|
Number of Embryos Frozen at Day 24
Time Frame: Approximately Day 24
|
The number of embryos that were not transferred but instead were frozen for future use.
|
Approximately Day 24
|
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
Time Frame: Day 1 to Day 24
|
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).
|
Day 1 to Day 24
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Participants With Biochemical Pregnancy at Day 38
Time Frame: approximately day 38 (Day 14 post embryo transfer)
|
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
|
approximately day 38 (Day 14 post embryo transfer)
|
Participants With Clinical Pregnancy at Week 7
Time Frame: approximately week 7
|
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
|
approximately week 7
|
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Time Frame: Day 1 - week 12
|
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. |
Day 1 - week 12
|
Number of Live Births
Time Frame: Approximately 10 months
|
Approximately 10 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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