Effect of Estradiol Pretreatment on Antagonist ICSI Cycles

January 20, 2022 updated by: Alexandria University

Studying The Effect of Estradiol Pretreatment on Follicular Synchronization and Intracytoplasmic Sperm Injection (ICSI) Outcome in Antagonist Cycles

Depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual follicle stimulating hormone (FSH) elevation that occurs during the late luteal phase, the aim of this work is to study the effect of estradiol pretreatment on follicular synchronization and intracytoplasmic sperm injection (ICSI) outcome in antagonist cycles

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gonadotropin-releasing hormone antagonist (GnRH-ant) cycles are characterized by higher patient acceptability with more attention being directed to the potential effect of steroid pretreatment to program antagonist protocol cycles, as marked size discrepancies of growing follicles reflect incoordinated maturation of follicular-oocyte complexes and complicates clinical criteria for human chorionic gonadotropin (hCG) administration. This phenomenon is associated with fewer mature oocytes and resulting embryos, which limits sufficient embryo selection for embryo transfer. Indeed, the large number of available embryos represented an important prognostic factor of invitro-fertilization (IVF) outcome, particularly in poor prognosis patients, possibly by increasing the probability that at least one good-quality embryo will be selected for embryo transfer. During COH, a better understanding of follicular development has resulted in the improvement of strategies for ovarian stimulation. This approach represents a potential and more physiological alternative to GnRH agonist or oral contraceptive pills pre-treatment in a trial to synchronize multi-follicular development and improve controlled ovarian hyperstimulation (COH) results. The present study is a randomized controlled trial that investigated whether E2 pre-treatment during the luteal phase affects developmental characteristics of growing follicles during COH. It depended on the hypothesis that growth asynchrony of antral follicles is a consequence of the gradual FSH elevation that occurs during the late luteal phase, thus testing for detection of the effect of luteal estradiol on follicular synchronization and its effect on ICSI outcome.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

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
      • Alexandria, Egypt
        • IVF center

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

20 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women age 20-37 years.
  2. Anti-mullerian (AMH) level greater than 1.2 ng/ml.
  3. Body mass index between 18 and 29 kg/m2.
  4. Undergoing a first or second ICSI cycles.

Exclusion Criteria:

  1. Endometriosis.
  2. Uterine disorders such as fibroids and uterine anomalies.
  3. Antral follicular counts (AFC) less than 10.
  4. Azoospermic males.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Cases who received estradiol pretreatment then underwent ICSI.
Drug: Estradiol Valerate 4mg
Estradiol valerate 2 mg (two tablet once daily) started 5 days before expected menses (or 7 days after ovulation of previous cycle). After start of menses, estradiol pretreatment was stopped and controlled ovarian stimulation started.
Other Names:
  • Progynova
No Intervention: group 2
Cases who underwent ICSI directly without receiving any pretreatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of stimulation.
Time Frame: 7-16 days after start of controlled ovarian stimulation.
number of days from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration until day of hCG administration
7-16 days after start of controlled ovarian stimulation.
Total number of gonadotropin ampoules used.
Time Frame: 7-16 days after start of controlled ovarian stimulation.
number of gonadotropin ampules used from the start of controlled ovarian stimulation on day 2 of menses until the day of hCG administration
7-16 days after start of controlled ovarian stimulation.
Total number of follicles by U/S on day of hCG.
Time Frame: 7-16 days after start of controlled ovarian stimulation.
number of follicles by ultrasound scan on day of hCG administration
7-16 days after start of controlled ovarian stimulation.
Serum estradiol and progesterone level on day of hCG .
Time Frame: 7-16 days after start of controlled ovarian stimulation.
serum level of estradiol pg/dl and progesterone ng/dl on day of hCG administration
7-16 days after start of controlled ovarian stimulation.
Endometrial thickness on day of hCG.
Time Frame: 7-16 days after start of controlled ovarian stimulation.
thickness of endometrium in mm on day of hCG
7-16 days after start of controlled ovarian stimulation.
Number of mature oocytes
Time Frame: 36 hours after oocyte retrieval.
number of metaphase II oocytes after denudation
36 hours after oocyte retrieval.
Number of good quality embryos.
Time Frame: 3 days after oocyte retrieval.
number of grade 1 and grade 2 day 3 embryos
3 days after oocyte retrieval.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 14 days after embryo transfer
the number of positive pregnancies (defined as serum B-hCG more than 5 miu/ml measured 14 days after embryo transfer) divided by the number of embryo transfer procedures.
14 days after embryo transfer
Clinical pregnancy rate
Time Frame: 2 weeks after positive pregnancy test
The number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures
2 weeks after positive pregnancy test

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Sherif Hebisha, phD, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2020

Primary Completion (Actual)

February 20, 2021

Study Completion (Actual)

November 15, 2021

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 3, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0106351

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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