Initiation of ovarian stimulation in the late follicular phase

Phase 1

• Conditions: Subfertility Oocyte donation; MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872; MedDRA version: 20.0 Level: PT Classification code 10053370 Term: Oocyte donation System Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2017-005005-12-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-08
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 62

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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/or AMH >5ng/ml (Fraissinet A et al, 2017)
•Endometriosis grade 3-4
•Oligo-amenorrhea
•Any untreated endocrine abnormality

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified