Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 3

Conditions: Infertility, Female

Treatments: Combination Product: Late follicular phase stimulation with recombinant-human FSH; Combination Product: Early follicular phase stimulation with recombinant-human FSH

Study type: Interventional

Funder types: Other

Identifiers

NCT03767218

D2.D12.Bemfola

Details and patient eligibility

About

A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.

Full description

Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.

Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio

Patients: Oocyte donors (aged 18-36 years)

Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.

Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.

Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.

Enrollment: 71 patients

Sex: Female

Ages: 18 to 36 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• oocyte donor patients
• Age from 18 to 36 years
• BMI 19 to 35
• Regular menstrual cycle length i.e. 24-35 days

Exclusion criteria

• Patients with AMH <1.1 ng/ml and/or AFC<7
• Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH >5ng/ml
• Endometriosis grade 3-4
• Oligo-amenorrhea
• Any untreated endocrine abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Late follicular phase stimulation with recombinant-human FSH

Experimental group

Description:

Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH \> 10 IU/L, till day of trigger.

Treatment:

Combination Product: Late follicular phase stimulation with recombinant-human FSH

Early follicular phase stimulation with recombinant-human FSH

Active Comparator group

Description:

Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.

Treatment:

Combination Product: Early follicular phase stimulation with recombinant-human FSH