Phase 4
N=122
Menopur Mixed Protocol
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT01417195 ↗Enrolled (actual)
122
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Fertilization Rate — 63.14; 59.56 percentage of oocytes retrieved
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bravelle (Drug); Menopur (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fertilization Rate |
63.14; 59.56 | — |
| SECONDARY Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1 |
60; 60; 60; 60; 60; 60 | — |
| SECONDARY Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6 |
60; 60; 60; 60; 60; 60 | — |
| SECONDARY Summary of Assessor Questionnaire on Day 1 |
60; 60; 60; 60; 60; 60 | — |
| SECONDARY Summary of Assessor Questionnaire on Day 6 |
60; 60; 60; 60; 60; 60 | — |
| SECONDARY Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS) |
29; 30; 9; 13; 0; 1 | — |
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 subjects undergoing Assisted Reproductive Technology (ART). Additionally the study assessed subjects' ability to mix and store the combination of Menopur and Bravelle and to assess safety of the Menopur and Bravelle combination.
Eligibility Criteria
Main Inclusion Criteria:
- 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 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
Data sourced from ClinicalTrials.gov (NCT01417195). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.