Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

Cairo University (CU)

Status: Enrolling

Conditions: Endometriosis

Treatments: Drug: Combined contraceptive pills (Yasmin)

Study type: Interventional

Funder types: Other

Identifiers

NCT06577974

MD-70-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 129 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 3 patient groups

Those treated by COCPs before IVSI

Experimental group

Description:

Those with endometrisosis who will undergo ICSI after pretreatment with COCPs

Treatment:

Drug: Combined contraceptive pills (Yasmin)

Those treated by Dionogest before ICSI

Experimental group

Description:

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

Treatment:

Drug: Combined contraceptive pills (Yasmin)

Those undergoing ICSI straighaway

No Intervention group

Description:

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