Status:
UNKNOWN
Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization
Lead Sponsor:
Ain Shams University
Conditions:
ICSI
Eligibility:
FEMALE
35-44 years
Phase:
PHASE3
Brief Summary
The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol level on implan...
Eligibility Criteria
Inclusion
- Participants included in this study will have the following criteria : ( 2 of 3 criteria )
- advanced maternal age or any other risk factor for POR :
- Age ≥35 years
- other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.
- previous poor ovarian response : Number of oocytes at the pickup time 3 or less .
- Abnormal ovarian reserve tests :
- FSH ≥12 mIu/ml in the early follicular phase .
- Estradiol level more than 70 pg/dl in the early follicular phase
- Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
- Antral follicle count (AFC) \< 5-7 follicles .
Exclusion
- Age \>35 with good ovarian response .
- any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
- Severe male factor infertility.
- Extended endometriosis (stage 3 or more) .
- All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2019
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03788681
Start Date
April 1 2018
End Date
September 1 2019
Last Update
December 27 2018
Active Locations (1)
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1
AinShams university maternity hospital
Cairo, Abbassya, Egypt, 11566