NATural Ovarian Stimulation

• Status: Completed
• Trial end date: 2019-02-08
• Target enrollment: 0
• Participant gender: Female

Summary

To overcome unsuitable effects of controlled ovarian hyperstimulation (COH )while maintaining large oocyte availability, investigators elaborated an innovative protocol (NATural Ovarian Stimulation) that dissociates E2 production from multiple follicle development.

The purpose of this prospective, randomized trial is to demonstrate that, in a good prognosis IVF-ET population, the physiological E2 environment resulting from NATOS significantly improves IVF-ET outcome when compared to the conventional GnRH antagonist protocol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: MerckSerono Pharmaceuticals
• Treatments: Cetrorelix

Criteria

Inclusion Criteria:

• IVF-ET candidates (excluding PGD and oocyte donor);

• Body mass index from 18 to 30 kg/m2;

• Non smokers;

• Regular menstrual cycles (25-35 days);

• Presence of both ovaries;

• Antral follicle count (follicles measuring from 3 to 10 mm in diameter) ranging from 10 to 30 on cycle days 2 to 4;

• Serum AMH levels ranging from 0.5 to 5.0 ng/mL;

• Normal endometrium at ultrasound (US) and/or hysteroscopy;

• Informed consent signed

Exclusion Criteria:

• Iatrogenic ovarian insufficiency (surgery, radiotherapy, chemotherapy);

• Uterine abnormalities as demonstrated by pelvic US and/or hysteroscopy;

• Usual contra-indications for COH (cancer risk, blood coagulation disorders, etc)

• Renal insufficiency