Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
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| ClinicalTrials.gov Identifier: NCT00805935 |
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Recruitment Status :
Completed
First Posted : December 10, 2008
Results First Posted : January 25, 2012
Last Update Posted : January 27, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycystic Ovarian Syndrome Infertility | Drug: Menotropin Drug: Progesterone vaginal insert Drug: Follitropin beta Drug: Progesterone in oil Drug: leuprolide acetate | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients |
| Study Start Date : | January 2009 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | September 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Menotropin/Progesterone vaginal insert
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 vaginal insert (Endometrin®) 100 mg 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
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Other Name: Menopur® Drug: Progesterone vaginal insert 100 mg inserted vaginally 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 Name: Endometrin® Drug: leuprolide acetate Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Other Name: Lupron |
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Experimental: Menotropin/Progesterone in oil
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 50 mg 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
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Other Name: Menopur® Drug: Progesterone in oil 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. Drug: leuprolide acetate Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Other Name: Lupron |
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Active Comparator: Follitropin beta/Progesterone vaginal insert
Follitropin beta (Follistim Pen®) 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 vaginal insert (Endometrin®) 50 mg 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: Progesterone vaginal insert
100 mg inserted vaginally 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 Name: Endometrin® Drug: Follitropin beta 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Other Name: Follistim Pen® Drug: leuprolide acetate Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Other Name: Lupron |
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Active Comparator: Follitropin beta/Progesterone in oil
Follitropin beta (Follistim Pen®) 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 50 mg 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
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.
Other Name: Follistim Pen® Drug: Progesterone in oil 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. Drug: leuprolide acetate Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.
Other Name: Lupron |
- Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3 [ Time Frame: weeks 1-3 ]A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
- Number of Follicles Observed at Day 15 [ Time Frame: approximately day 15 ]The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
- Number of Oocytes Retrieved at Day 18 [ Time Frame: approximately day 18 ]The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.
- Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved [ Time Frame: approximately day 19 ]The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.
- Number of Embryos Transferred at Three Stages of Development Before Implantation [ Time Frame: approximately day 24 ]
The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.
Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.
- Number of Embryos Frozen [ Time Frame: approximately day 24 ]The number of embryos that were not transferred but instead were frozen for future use.
- Percentage of Participants With Biochemical Pregnancy at Approximately 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.
- Percentage of Participants With Clinical Pregnancy at Week 7 [ Time Frame: approximately Day 52 ]Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
- Percentage of Participants With Ongoing Pregnancy at Week 9 [ Time Frame: approximately Day 65 ]Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
- Estradiol Levels at Day 6 [ Time Frame: Day 6 ]Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.
- Human Chorionic Gonadotropin (hCG) Levels at Day 6 [ Time Frame: Day 6 ]Blood tests were sent to a central laboratory to obtain hCG levels.
- Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration [ Time Frame: approximately day 16 ]Blood tests were sent to a central laboratory to obtain progesterone levels.
- Number of Live Births Resulting From the In Vitro Fertilization Process [ Time Frame: Approximately 10 months ]Number of live births resulting from the IVF process
- Participants With Treatment Emergent Adverse Events [ Time Frame: Week 1 to week12 ]
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.
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| Ages Eligible for Study: | 18 Years to 42 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Pre-menopausal females between the ages of 18 and 42 years
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Diagnosed with polycystic ovary syndrome (PCOS), using criteria adopted as the 2003 Rotterdam PCOS Consensus (2 out of 3, excluding other etiologies [congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome])
- Oligo- or anovulation
- Clinical and/or biochemical signs of hyperandrogenism
- Polycystic ovaries
- Body mass index (BMI) of 18-39
- Early follicular phase (Day 3) 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., uncontrolled thyroid or adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, 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
- Two or more previous failed in vitro fertilization (IVF) cycles or in vitro fertilization (IVF)/assisted reproductive technology (ART) failure due to a poor response to gonadotropins, defined as development of 2 mature follicles
- History of recurrent pregnancy loss, defined as more than two clinical losses
- 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])
- Prior hypersensitivity to any of the protocol drugs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00805935
| United States, Colorado | |
| Conceptions Reproductive Associates of Colorado | |
| Littleton, Colorado, United States, 80129 | |
| United States, Florida | |
| Women's Medical Research Group LLC, Florida | |
| Clearwater, Florida, United States, 33759 | |
| United States, Illinois | |
| Fertility Center of Illinois | |
| Chicago, Illinois, United States, 60610 | |
| United States, New York | |
| Weill Cornell Medical College | |
| New York, New York, United States, 10021 | |
| United States, Rhode Island | |
| Women & Infants' Hospital of RI | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Texas | |
| Center for Assisted Reproduction | |
| Bedford, Texas, United States, 76022 | |
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00805935 |
| Other Study ID Numbers: |
2008-05 |
| First Posted: | December 10, 2008 Key Record Dates |
| Results First Posted: | January 25, 2012 |
| Last Update Posted: | January 27, 2012 |
| Last Verified: | January 2012 |
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pre-menopausal women PCOS polycystic ovarian syndrome |
infertility IVF in vitro fertilization |
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Polycystic Ovary Syndrome Infertility Syndrome Disease Pathologic Processes Genital Diseases Urogenital Diseases Ovarian Cysts Cysts Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |
Gonadal Disorders Endocrine System Diseases Leuprolide Menotropins Progesterone Follicle Stimulating Hormone Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Fertility Agents, Female Fertility Agents Reproductive Control Agents Antineoplastic Agents, Hormonal Antineoplastic Agents |