NCT03767218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

May 16, 2023

Status Verified

April 1, 2022

Enrollment Period

3.6 years

First QC Date

May 17, 2018

Last Update Submit

May 12, 2023

Conditions

Infertility, Female

Keywords

Oocyte donorOvarian stimulation

Outcome Measures

Primary Outcomes (1)

  • total amount of COC (cumulus-oocyte-complex)

    at oocyte aspiration

Secondary Outcomes (9)

  • Endocrine profile

    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

    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

    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

    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

    during the ovarian stimulation

  • +4 more secondary outcomes

Study Arms (2)

Late follicular phase stimulation with recombinant-human FSH

EXPERIMENTAL

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

Early follicular phase stimulation with recombinant-human FSH

ACTIVE COMPARATOR

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

Interventions

Late follicular phase stimulation with recombinant-human FSHCOMBINATION_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.

Late follicular phase stimulation with recombinant-human FSH
Early follicular phase stimulation with recombinant-human FSHCOMBINATION_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.

Early follicular phase stimulation with recombinant-human FSH

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

December 6, 2018

Study Start

November 1, 2018

Primary Completion

May 27, 2022

Study Completion

November 25, 2022

Last Updated

May 16, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

BE(1)