Skip to main content
OpenTrials
Completed

NCT Number: NCT03767218

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

18 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late follicular phase stimulation with recombinant-human FSH

Combination Product

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

Combination Product

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.

Primary outcomes

  1. total amount of COC (cumulus-oocyte-complex)

    Time frame: at oocyte aspiration

Secondary outcomes

  1. Endocrine profile

    Time frame: 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

    LH (Luteinising hormone) level

  2. Endocrine profile

    Time frame: 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

    FSH level

  3. Endocrine profile

    Time frame: 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

    Progesterone level

  4. Endocrine profile

    Time frame: 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

    Estradiol level

  5. Consumption of gonadotrophins

    Time frame: during the ovarian stimulation

    totaal amount of IU (international units) used

  6. Number of days needed for ovarian stimulation

    Time frame: during the ovarian stimulation

  7. Days of GnRH antagonist use

    Time frame: during the ovarian stimulation

  8. Total number of mature oocytes

    Time frame: at day of oocyte aspiration

  9. Total medication cost

    Time frame: during the ovarian stimulation

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2018
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.