uteal phase ovarian stimulation with Follitropin delta and dydrogesterone
Phase 1
- Conditions
- Volutary women who wish to donate their oocytesTherapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
- Registration Number
- CTIS2024-513998-48-00
- Lead Sponsor
- niversitair Ziekenhuis Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Age from= 18 to = 36 years, BMI =18 to < 28, Signed informed consent, Regular menstrual cycle length i.e. 24-35 days
Exclusion Criteria
Contraindications to the use of gonadotropins, Endometriosis grade 3-4, Patients with AMH <1.1 ng/ml and/or AFC<7, Patients with FNPO (Follicle Number Per Ovary) = 19 and/or AMH >5ng/ml, Patients under contraception with hormonal 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 donor patients.;Primary end point(s): Total number of retrieved COCs
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Endocrine profile in both treatment groups;Secondary end point(s):Consumption (mcg) of gonadotrophins;Secondary end point(s):Duration of ovarian stimulation;Secondary end point(s):Days of progestin use;Secondary end point(s):Total number of MII oocytes