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Role of Medical Treatment in Endometriosis Patients Undergoing ICSI

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06577974
Enrollment
129
Registered
2024-08-29
Start date
2024-07-01
Completion date
2025-03-01
Last updated
2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Keywords

Oocyte yield, fertilisation rate

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.

Interventions

DRUGCombined contraceptive pills (Yasmin)

medical pretreatment prior to ICSI

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Fertilisation rate2 weeks from starting inductionNumber of embryos

Secondary

MeasureTime frameDescription
clinical pregnancy rate2 weeks from embryo transferappearance of intrauterine gestational sac

Countries

Egypt

Contacts

Primary ContactMariam Dawoud, A. Professor
zdawoud9@gmail.com01157355666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026