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

Phase 3

• Conditions: ICSI
• Interventions: Drug: Placebo Oral Tablet; Drug: Estradiol Valerate

• Registration Number: NCT03788681
• Lead Sponsor: Ain Shams University

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2018-12
• Study First Submitted: 2018-12-26
• Study First Submitted QC: 2018-12-26
• Last Update Submitted: 2018-12-26
• Study First Posted: 2018-12-27
• Last Update Posted: 2018-12-27
• Primary Completion: 2019-08-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 170

Inclusion Criteria

• Participants included in this study will have the following criteria : ( 2 of 3 criteria )

  1. advanced maternal age or any other risk factor for POR :

     1. Age ≥35 years
     2. other risk factor of poor responder : ovarian surgery especially in case of endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single ovary, chronic smoking, and unexplained Infertility.

  2. previous poor ovarian response : Number of oocytes at the pickup time 3 or less .

  3. Abnormal ovarian reserve tests :

     1. FSH ≥12 mIu/ml in the early follicular phase .
     2. Estradiol level more than 70 pg/dl in the early follicular phase
     3. Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.
     4. Antral follicle count (AFC) < 5-7 follicles .

Exclusion Criteria

1. Age >35 with good ovarian response .
2. any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal fibroid , intra-uterine adhesions ).
3. Severe male factor infertility.
4. Extended endometriosis (stage 3 or more) .
5. All contraindications for estradiol : venous thrombo-embolism , stroke and breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo Oral Tablet	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
oral estradiol " estradiol valerate	Estradiol Valerate	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.

Primary Outcome Measures

Name	Time	Method
live birth rate	at least 28 weeks after ET	the number of deliveries that resulted in a live born neonate

Trial Locations

Locations (1)

AinShams university maternity hospital; 🇪🇬 Cairo, Abbassya, Egypt