Menopur Mixed Protocol

Infertility Clinical Trial

— COMBINE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01417195
• Other study ID #: FE999906 CS12
• Status: Completed
• Phase: Phase 4
• First received: July 28, 2011
• Last updated: May 6, 2014
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2014
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

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:
• Bravelle

• Menopur

Locations

Country	Name	City	State
United States	Reproductive Biology Associates	Atlanta	Georgia
United States	The Center for Assisted Reproduction	Bedford	Texas
United States	Fertility Center of Illinois	Chicago	Illinois
United States	Women's Medical Research Group	Clearwater	Florida
United States	Houston Fertility Institute	Houston	Texas
United States	Colorado Center for Reproductive Medicine	Lone Tree	Colorado
United States	The Advanced IVF Institute	Naperville	Illinois
United States	Shady Grove Fertility	Rockville	Maryland
United States	Seattle Reproductive Medicine	Seattle	Washington
United States	Center of Reproductive Medicine	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	No
Secondary	Summary of the Subject Comprehension Questionnaire (SCQ) on Day 1	Subject comprehension questionnaires were completed on Day 1 only by participants assigned to the Menopur and Bravelle treatment arm. On Day 1, the participant read the Mixing Instructions Guide on how to mix and administer the medications at home. The participant was given enough time to read and understand the instructions and ask any questions. The participant then completed the SCQ which consists of 7 questions with YES/NO answers, to self-gauge their understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).	Day 1	No
Secondary	Summary of the Subject Comprehension Questionnaire (SCQ) on Day 6	Subject comprehension questionnaires were repeated on Day 6 after 5 days of combination therapy by participants assigned to the Menopur and Bravelle treatment arm. The SCQ consists of 7 questions with YES/NO answers to self-gauge participants' understanding of drug administration procedures. Reported data represent the number of participants who answered the question YES. Gonadotropins are referred to as investigational medicinal product (IMP).	Day 6	No
Secondary	Summary of Assessor Questionnaire on Day 1	Participants assigned to the Menopur and Bravelle treatment arm read the Mixing Instructions Guide on how to mix and administer the medications at home. Participants were given enough time to read and understand the instructions and ask any questions. After completing the SCQ, participants prepared and self-administered her assigned first daily dose in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.; Gonadotropins are referred to as investigational medicinal product (IMP).	Day 1	No
Secondary	Summary of Assessor Questionnaire on Day 6	Participants assigned to the Menopur and Bravelle treatment arm prepared and self-administered her daily dose on Day 6 in the presence of the study coordinator or designee assessor. The assessor then completed a 7 question questionnaire with YES or NO answers to document their assessment of participant understanding of drug administration procedures. Reported data represent the number of participants for whom the assessor answered the question YES.; Gonadotropins are referred to as investigational medicinal product (IMP).	Day 6	No
Secondary	Participants With Treatment Emergent Adverse Events (TEAEs), Including Ovarian Hyperstimulation Syndrome (OHSS)	A treatment-emergent AE was any AE occurring after start of investigational medicinal product (IMP) and within the time of residual drug effect, or a pretreatment AE or pre-existing medical condition that worsened in intensity after start of IMP and within the time of residual drug effect. The time of residual drug effect was the estimated period of time after the last dose of the IMP, where the effect of the product was still considered to be present based on pharmacokinetic, pharmacodynamic, or other IMP characteristics.	Day 1 up to Day 20	Yes