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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767218
• Other study ID #: D2.D12.Bemfola
• Status: Completed
• Phase: Phase 3
• Start date: November 1, 2018
• Est. completion date: November 25, 2022

Study information

• Verified date: April 2022
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 25, 2022
• Est. primary completion date: May 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total amount of COC (cumulus-oocyte-complex)		at oocyte aspiration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Consumption of gonadotrophins	totaal amount of IU (international units) used	during the ovarian stimulation
Secondary	Number of days needed for ovarian stimulation		during the ovarian stimulation
Secondary	Days of GnRH antagonist use		during the ovarian stimulation
Secondary	Total number of mature oocytes		at day of oocyte aspiration
Secondary	Total medication cost		during the ovarian stimulation