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

December 26, 2018 updated by: Radwa Rasheedy Ali, Ain Shams University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Abbassya
      • Cairo, Abbassya, Egypt, 11566
        • Recruiting
        • AinShams university maternity hospital
        • Contact:
          • Mostafa f Gomaa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 44 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: oral estradiol " 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.
Drug: Estradiol Valerate
oral estradiol " estradiol valerate " (Cyclo-Progynova)
PLACEBO_COMPARATOR: placebo
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
placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ANTICIPATED)

August 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

December 26, 2018

First Submitted That Met QC Criteria

December 26, 2018

First Posted (ACTUAL)

December 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2018

Last Update Submitted That Met QC Criteria

December 26, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams Univ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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