Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

August 27, 2024 updated by: Mariam Ahmed Mohamed Dawoud, Cairo University

Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy

The aim of this study to assess the effect of medical treatment prior to stimulation on fertility (ICSI) outcome in cases with endometriosis associated infertility.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients complaining of infertility due to endometriosis diagnosed by ultrasound or laparoscopic surgery will be randomly allocated to three groups :

Group A: will receive COCPs for 3-6 months prior to starting IVF / ICSI cycle. Group B: will receive Dienogest for 3-6 months prior to starting IVF / ICSI cycle.

Group C: will be subjected to direct ICSI /IVF cycle. Then all patients will be subjected to ovarian stimulation regimen using GnRH Agonist Down-Regulation Gonadotropin Stimulation-The "Long" Protocol.

During the ovarian stimulation, the woman's response is monitored with serum estradiol levels and vaginal ultrasound examinations. The estradiol level is used to determine the dose of gonadotropins and whether under- or overstimulation occurs. The goal of the ovarian hyperstimulation is to develop at least three mature follicles that are 17 mm in diameter or larger. Once this is achieved, FSH and other medications are discontinued, and a single injection of hcg is given to mature the eggs to allow fertilization.

The hcg administration will also cause ovulation, but this does not occur until 40 hours or later after the injection. Therefore, it is standard that the hcg injection is administered 36 hours before the scheduled egg retrieval such that this will allow adequate maturation of the eggs and yet there would be little risk of ovulation.

Then the process will be continued through oocyte retrieval, oocyte maturation , fertilization by ICSI.

Each group will be followed up to detect the number of oocyte yield, fertilization rate and availability of good quality embryos and then according to the results the effect of medical treatment prior to stimulation will be assessed.

Study Type

Interventional

Enrollment (Estimated)

129

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • ART unit, Obstetrics and Gynecology Department, Cairo University
        • Contact:
          • Mariam Dawoud, MD
      • Cairo, Egypt
        • Recruiting
        • Cairo University/Obstetrics and Gynecology Department/ART Unit
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of Endometrioma on ultrasound.
  • History of ovarian cystectomy either open or via laparoscopic surgery.
  • Presence of endometriotic foci in the pelvis during laparoscopic surgery.
  • Patients coming for the first ICSI / IVF cycle.

Exclusion Criteria:

  • Age above 40 years
  • Cases with endometrioma on ultrasound more than 3 cm size.
  • Prior failed ICSI / IVF.
  • Known poor responders or poor ovarian reserve, defined as AFC<5 or AMH < 0.5 .
  • Patients with previous uterine surgery.
  • Patients diagnosed to have uterine abnormalities

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Those treated by COCPs before IVSI
Those with endometrisosis who will undergo ICSI after pretreatment with COCPs
Drug: Combined contraceptive pills (Yasmin)
medical pretreatment prior to ICSI
Other Names:
  • Dienogest (Visanne)
Experimental: Those treated by Dionogest before ICSI
Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest
Drug: Combined contraceptive pills (Yasmin)
medical pretreatment prior to ICSI
Other Names:
  • Dienogest (Visanne)
No Intervention: Those undergoing ICSI straighaway
patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilisation rate
Time Frame: 2 weeks from starting induction
Number of embryos
2 weeks from starting induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 2 weeks from embryo transfer
appearance of intrauterine gestational sac
2 weeks from embryo transfer

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Ahmed Taha, Professor, Cairo 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)

July 1, 2024

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 16, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-70-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, excel sheet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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