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

Primary Purpose

Infertility, Female

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Late follicular phase stimulation with recombinant-human FSH
Early follicular phase stimulation with recombinant-human FSH
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring Oocyte donor, Ovarian stimulation

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept 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:

  • Contraindications to the use of gonadotropins
  • 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
  • Elevated serum estradiol (E2>80pg/ml) on day 2 blood sample
  • Any untreated endocrine abnormality

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Late follicular phase stimulation with recombinant-human FSH

Early follicular phase stimulation with recombinant-human FSH

Arm 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.

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.

Outcomes

Primary Outcome Measures

total amount of COC (cumulus-oocyte-complex)

Secondary Outcome Measures

Endocrine profile
LH (Luteinising hormone) level
Endocrine profile
FSH level
Endocrine profile
Progesterone level
Endocrine profile
Estradiol level
Consumption of gonadotrophins
totaal amount of IU (international units) used
Number of days needed for ovarian stimulation
Days of GnRH antagonist use
Total number of mature oocytes
Total medication cost

Full Information

First Posted
May 17, 2018
Last Updated
May 12, 2023
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT03767218
Brief Title
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
Official Title
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
November 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
Oocyte donor, Ovarian stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Late follicular phase stimulation with recombinant-human FSH
Arm Type
Experimental
Arm 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.
Arm Title
Early follicular phase stimulation with recombinant-human FSH
Arm Type
Active Comparator
Arm 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.
Intervention Type
Combination Product
Intervention Name(s)
Late follicular phase stimulation with recombinant-human FSH
Intervention 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.
Intervention Type
Combination Product
Intervention Name(s)
Early follicular phase stimulation with recombinant-human FSH
Intervention 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.
Primary Outcome Measure Information:
Title
total amount of COC (cumulus-oocyte-complex)
Time Frame
at oocyte aspiration
Secondary Outcome Measure Information:
Title
Endocrine profile
Description
LH (Luteinising hormone) level
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
Title
Endocrine profile
Description
FSH level
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
Title
Endocrine profile
Description
Progesterone level
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
Title
Endocrine profile
Description
Estradiol level
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
Title
Consumption of gonadotrophins
Description
totaal amount of IU (international units) used
Time Frame
during the ovarian stimulation
Title
Number of days needed for ovarian stimulation
Time Frame
during the ovarian stimulation
Title
Days of GnRH antagonist use
Time Frame
during the ovarian stimulation
Title
Total number of mature oocytes
Time Frame
at day of oocyte aspiration
Title
Total medication cost
Time Frame
during the ovarian stimulation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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