Clinical trial NCT06577974: Role of Medical Treatment in Endometriosis Patients Undergoing ICSI
Official title: Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: Oocyte yield, fertilisation rate
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 129
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Fertilisation rate
timeFrame: 2 weeks from starting induction
Secondary outcomes:
measure: clinical pregnancy rate
timeFrame: 2 weeks from embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: ART unit, Obstetrics and Gynecology Department, Cairo University
city: Cairo
country: Egypt
facility: Cairo University/Obstetrics and Gynecology Department/ART Unit
Study officials:
affiliation: Cairo University
name: Ahmed Taha, Professor
role: STUDY_CHAIR
References: