Clinical trial

Interest of Estrogen Scheduling Before Ovarian Stimulation With Corifollitropin Alfa in Women Older Than 38 Years Old Undergoing in Vitro Fertilization

Name
PRESCORI
Description
E2 given in late luteal phase can be extended beyond the onset of menses for a period of at least eight days before the start of the stimulation, allowing scheduling of stimulation in order to limit oocytes retrievals during weekends . Administration of corifollitropin alfa, a Follicule stimulating Hormone (FSH) with extended release kinetics, seems particularly interesting for a synchronous recruitment of follicles after homogenization of the cohort. The objective of this study is to evaluate the impact on the response to ovarian stimulation with corifollitropin alfa of E2 scheduling versus no scheduling for women over 38 years, age at which declining of ovarian reserve usually begins. The management of these patients in terms of organization of the center is also evaluated. The scheduling of IVF cycles represents a double benefit. On one hand, to enable a "synchronization" of the follicular cohort for a best response and a higher number of mature oocytes. On the other hand, a more efficient organization for both the center (avoiding retrievals on weekends and public holidays, organize and distribute equally the activity, reduce cost operations) and couples (personal and professional organization).
Trial arms
Trial start
2016-11-04
Estimated PCD
2022-07-01
Trial end
2023-01-04
Status
Completed
Phase
Early phase I
Treatment
Estrogens
The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses
Arms:
Arm E2: With estrogens pretreatment
Size
334
Primary endpoint
Number of selected oocytes
At time of ovarian puncture
Eligibility criteria
Inclusion Criteria: * Patient of 38 years or more * Planned in invitro fertilization or intracytoplasmic sperm injection rank 1 or 2 (rank = retrieval with transfer) * With regular cycles from 26 to 35 days * Weight \> 50 kg and body mass index\< or equal to 32 * Affiliation to the general system of French social security and reimbursement for fertility problems Exclusion Criteria: * Irregular cycles and/or polycystic ovarian syndrome * Previous History of ovarian hyperstimulation syndrome * Rank puncture \> 2 * Uterine malformation * Presence of hydrosalpinges * Endometriosis stage III or IV
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 334, 'type': 'ACTUAL'}}
Updated at
2023-02-08

1 organization

1 product

1 indication

Product
Estrogens
Indication
infertility