Menopur Mixed Protocol
COMBINE
A Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Combination of Menopur® and Bravelle® With Menopur® Alone in Subjects Undergoing Assisted Reproductive Technology (ART)
1 other identifier
interventional
122
1 country
10
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2011
Shorter than P25 for phase_4
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
April 24, 2014
CompletedMay 16, 2014
May 1, 2014
6 months
July 28, 2011
March 20, 2014
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fertilization Rate
The fertilization rate was defined for each participant and calculated as the number of 2 pronuclei (fertilized) (2PN) oocytes divided by the total number of oocytes retrieved multiplied by 100.
approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))
Secondary Outcomes (5)
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
Day 1
Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
Day 6
Summary of Assessor Questionnaire on Day 1
Day 1
Summary of Assessor Questionnaire on Day 6
Day 6
Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Day 1 up to Day 20
Study Arms (2)
Menopur and Bravelle combination
EXPERIMENTALThe initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
Menopur alone
ACTIVE COMPARATORThe initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, United States
Women's Medical Research Group
Clearwater, Florida, United States
Reproductive Biology Associates
Atlanta, Georgia, United States
Fertility Center of Illinois
Chicago, Illinois, United States
The Advanced IVF Institute
Naperville, Illinois, United States
Shady Grove Fertility
Rockville, Maryland, United States
The Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Seattle Reproductive Medicine
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 16, 2011
Study Start
July 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
May 16, 2014
Results First Posted
April 24, 2014
Record last verified: 2014-05