uteal phase ovarian stimulation with Follitropin delta and dydrogesterone

Phase 1

Conditions: Volutary women who wish to donate their oocytes
Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Registration Number: EUCTR2022-003049-37-BE

Lead Sponsor: Z Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 50

Inclusion Criteria

•Age from = 18 to = 36 years
•Body mass Index (BMI) =18 to < 28
•Signed informed consent
•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 50
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
•Endometriosis grade 3-4
•Patients with Anti-mullerian hormone (AMH) <1.1 ng/ml and/or AFC<7
•Patients with Follicle Number Per Ovary (FNPO) = 19 and/or AMH >5ng/ml (Fraissinet A et al, 2017)
•Patients under contraception with hormonal intrauterine device (IUD)
•Any untreated endocrine abnormality

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of FE 999049 on the number of cumulus-oocyte complexes (COCs) when a Primed Progestin Ovarian Stimulation (PPOS) protocol is associated to both conventional follicular phase stimulation and Luteal phase Ovarian Stimulation (LPOS) protocol in oocyte donors.;Secondary Objective: To determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donors. ;Primary end point(s): total number of retrieved COCs ;Timepoint(s) of evaluation of this end point: Oocyte retrieval will take place 36h after triggering of final follicular maturation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Endocrine profile in both treatment groups <br>•Consumption (mcg) of gonadotrophins<br>•Duration of ovarian stimulation<br>•Days of progestin use <br>•Total number of MII oocytes <br>;Timepoint(s) of evaluation of this end point: •through study completion, an average of 1 year<br><br>•1-2 hours after oocyte retrieval]<br>