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NCT Number: NCT06577974

Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ART unit, Obstetrics and Gynecology Department, Cairo University, Cairo, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined contraceptive pills (Yasmin)

Drug

medical pretreatment prior to ICSI

Other names: Dienogest (Visanne)

Primary outcomes

  1. Fertilisation rate

    Time frame: 2 weeks from starting induction

    Number of embryos

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 2 weeks from embryo transfer

    appearance of intrauterine gestational sac

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Dawoud, A. Professor

CONTACT

[email protected]

01157355666

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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