Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

Study Overview
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Brief Summary
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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 implantation is not clearly defined . There is a significant difference in estradiol levels between fertile and infertile cycles of fertile women who underwent donor insemination.

Official Title
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Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization

Conditions
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ICSI

Intervention / Treatment
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* Drug: Estradiol Valerate
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral estradiol  estradiol valerate<br>this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol  estradiol valerate  (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle. | Drug: Estradiol Valerate<br>* oral estradiol  estradiol valerate  (Cyclo-Progynova)<br>|
| Placebo Comparator: placebo<br>this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle | Drug: Placebo Oral Tablet<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | the number of deliveries that resulted in a live born neonate | at least 28 weeks after ET |