MENOPUR® Versus FOLLISTIM®

Infertility Clinical Trial

Official title:

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00802360
• Other study ID #: 2008-04
• Status: Completed
• Phase: Phase 4
• First received: December 3, 2008
• Last updated: October 31, 2011
• Start date: December 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

1. Pre-menopausal females between the ages of 18 and 42 years

2. Body mass index (BMI) of 18-34

3. Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits

4. 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.)

5. Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa

6. Signed informed consent

Exclusion Criteria:

1. Gestational or surrogate carrier, donor oocyte

2. Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)

3. 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

4. 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.

5. History of recurrent pregnancy loss (>2).

6. Presence of abnormal uterine bleeding of undetermined origin

7. Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day

8. Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests

9. Participation in any experimental drug study within 30 days prior to Screening

10. Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Menotropin
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.
• Progestrone vaginal insert
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.
• follitropin beta
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.
• 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.
• Ganirelix
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.

Locations

Country	Name	City	State
United States	A Woman's Center for Reproductive Medicine	Baton Rouge	Louisiana
United States	Center for Assisted Reproduction	Bedford	Texas
United States	Women's Medical Research Group, LLC	Clearwater	Florida
United States	Conceptions Reproductive Associates of Colorado	Littleton	Colorado
United States	The Advanced IVF Institute; Charles E. Miller, MD & Associates	Naperville	Illinois
United States	Huntington Reproductive Center	Pasadena	California
United States	San Diego Fertility Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8 (Week 6 of gestation)	No
Secondary	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.	Day 15	No
Secondary	Number of Oocytes Retrieved at Day 18	The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.	Approximately Day 18	No
Secondary	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.	Approximately Day 19	No
Secondary	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.	Approximately Day 24	No
Secondary	Number of Embryos Frozen at Day 24	The number of embryos that were not transferred but instead were frozen for future use.	Approximately Day 24	No
Secondary	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).	Day 1 to Day 24	No
Secondary	Participants With Biochemical Pregnancy at Day 38	Biochemical pregnancy is a positive ß-hCG pregnancy test 12-14 days post embryo transfer.	approximately day 38 (Day 14 post embryo transfer)	No
Secondary	Participants With Clinical Pregnancy at Week 7	Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.	approximately week 7	No
Secondary	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.	Day 1 - week 12	Yes
Secondary	Number of Live Births		Approximately 10 months	No