Status:
COMPLETED
Menopur Mixed Protocol
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
Brief Summary
The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in...
Eligibility Criteria
Inclusion
- Main
- Infertile pre-menopausal female subjects
- Documented history of infertility (eg., unable to conceive for at least 1 year, or 6 months for women ≥36 years of age, or women with bilateral tubal occlusion or absence, or subjects who require donor sperm).
- Subject's male partner with semen analysis that was at least adequate for intracytoplasmic sperm injection (ICSI) within 6 months prior to the subjects beginning down-regulation with gonadotropin-releasing hormone (GnRH)-agonist. Partners with severe male factor requiring invasive or surgical sperm retrieval or donor sperm could have been used.
- Anti-mullerian hormone (AMH) \> 1 ng/mL and \< 3 ng/mL at screening.
- Eligible for in-vitro fertilisation (IVF) or ICSI treatment.
- Main
Exclusion
- Oocyte donor or embryo recipient; gestational or surrogate carrier
- Previous IVF or assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response was defined as development of ≤ 2 mature follicles or history of 2 previous failed cycle cancellations prior to oocyte retrieval due to poor response.
- Inadequate number of oocytes, defined as fewer than 5 oocytes retrieved in previous ART attempts.
- Subject's male partners with obvious leukospermia (\>2 million white blood cells \[WBC\]/mL) or signs of infection in semen sample within 2 months of the start of subject's pituitary down-regulation. If either of these conditions existed, the male was to be treated with antibiotics and retested prior to subject's pituitary down-regulation.
- Undergoing blastomere biopsy and other experimental ART procedures.
- Body mass index (BMI) of ≤18 and ≥32 kg/m\^2
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01417195
Start Date
July 1 2011
End Date
January 1 2012
Last Update
May 16 2014
Active Locations (10)
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1
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States
2
Women's Medical Research Group
Clearwater, Florida, United States
3
Reproductive Biology Associates
Atlanta, Georgia, United States
4
Fertility Center of Illinois
Chicago, Illinois, United States