Status:

COMPLETED

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

Lead Sponsor:

Universitair Ziekenhuis Brussel

Conditions:

Infertility, Female

Eligibility:

FEMALE

18-36 years

Phase:

PHASE3

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...

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 (G...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 25 2022

Estimated Enrollment :

71 Patients enrolled

Trial Details

Trial ID

NCT03767218

Start Date

November 1 2018

End Date

November 25 2022

Last Update

May 16 2023

Active Locations (1)

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Universitair Ziekenhuis Brussel

Brussels, Belgium, 1090