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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.

Conditions
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Infertility, Female

Intervention / Treatment
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* Combination Product: Late follicular phase stimulation with recombinant-human FSH
* Combination Product: Early follicular phase stimulation with recombinant-human FSH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Late follicular phase stimulation with recombinant-human FSH<br>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. | Combination Product: Late follicular phase stimulation with recombinant-human FSH<br>* 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.<br>|
| Active Comparator: Early follicular phase stimulation with recombinant-human FSH<br>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. | Combination Product: Early follicular phase stimulation with recombinant-human FSH<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total amount of COC (cumulus-oocyte-complex) |  | at oocyte aspiration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endocrine profile | LH (Luteinising hormone) level | on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | 
| Endocrine profile | FSH level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | 
| Endocrine profile | Progesterone level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | 
| Endocrine profile | Estradiol level | on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group | 
| Consumption of gonadotrophins | totaal amount of IU (international units) used | during the ovarian stimulation | 
| Number of days needed for ovarian stimulation |  | during the ovarian stimulation | 
| Days of GnRH antagonist use |  | during the ovarian stimulation | 
| Total number of mature oocytes |  | at day of oocyte aspiration | 
| Total medication cost |  | during the ovarian stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocyte donor, Ovarian stimulation