Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

NCT ID: NCT06577974

Last Updated: 2024-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-01

Brief Summary

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.

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.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Those treated by COCPs before IVSI

Those with endometrisosis who will undergo ICSI after pretreatment with COCPs

Group Type: EXPERIMENTAL

Combined contraceptive pills (Yasmin)

Intervention Type: DRUG

medical pretreatment prior to ICSI

Those treated by Dionogest before ICSI

Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest

Group Type: EXPERIMENTAL

Combined contraceptive pills (Yasmin)

Intervention Type: DRUG

medical pretreatment prior to ICSI

Those undergoing ICSI straighaway

patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Combined contraceptive pills (Yasmin)

medical pretreatment prior to ICSI

Intervention Type: DRUG

Other Intervention Names

Dienogest (Visanne)

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mariam Ahmed Mohamed Dawoud

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Taha, Professor

Role: STUDY_CHAIR

Cairo University

Locations

ART unit, Obstetrics and Gynecology Department, Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Cairo University/Obstetrics and Gynecology Department/ART Unit

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mariam Dawoud, A. Professor

Role: CONTACT

zdawoud9@gmail.com

01157355666

Facility Contacts

Mariam Dawoud, MD

Role: primary

Mariam Dawoud, A. Professor

Role: primary

zdawoud9@gmail.com

00201157355666

Other Identifiers

MD-70-2023

Identifier Type: -

Identifier Source: org_study_id