Clinical trial NCT01417195: Menopur Mixed Protocol
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Assisted Reproductive Technology
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-16
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \< 3 ng/mL at screening.
* Eligible for in-vitro fertilisation (IVF) or ICSI treatment.

Main Exclusion Criteria:

* 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

Primary outcomes:
measure: Fertilization Rate
timeFrame: approximately day 13 (16-20 hours post insemination by in vitro fertilization (IVF) insemination or intracytoplasmic sperm injection (ICSI))
Secondary outcomes:
measure: Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1
timeFrame: Day 1
measure: Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6
timeFrame: Day 6
measure: Summary of Assessor Questionnaire on Day 1
timeFrame: Day 1
measure: Summary of Assessor Questionnaire on Day 6
timeFrame: Day 6
measure: Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
timeFrame: Day 1 up to Day 20
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Colorado Center for Reproductive Medicine
state: Colorado
city: Clearwater
country: United States
facility: Women's Medical Research Group
state: Florida
city: Atlanta
country: United States
facility: Reproductive Biology Associates
state: Georgia
city: Chicago
country: United States
facility: Fertility Center of Illinois
state: Illinois
city: Naperville
country: United States
facility: The Advanced IVF Institute
state: Illinois
city: Rockville
country: United States
facility: Shady Grove Fertility
state: Maryland
city: Bedford
country: United States
facility: The Center for Assisted Reproduction
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Seattle
country: United States
facility: Seattle Reproductive Medicine
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: