Menopur Mixed Protocol (COMBINE)

Ferring

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Menopur; Drug: Bravelle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01417195

FE999906 CS12

Details and patient eligibility

About

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.

Enrollment: 122 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Menopur and Bravelle combination

Experimental group

Description:

The 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.

Treatment:

Drug: Bravelle

Drug: Menopur

Menopur alone

Active Comparator group

Description:

The 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.

Treatment:

Drug: Menopur