Overview

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