Role of Medical Treatment in Endometriosis Patients Undergoing ICSI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combined contraceptive pills (Yasmin).
- Who it may be relevant to
- Registry conditions: Endometriosis. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
Overview
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
- Drug Combined contraceptive pills (Yasmin)
medical pretreatment prior to ICSI
Primary outcome measures
- Fertilisation rate [Time frame: 2 weeks from starting induction]
Secondary outcome measures (1)
- clinical pregnancy rate [Time frame: 2 weeks from embryo transfer]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- ART unit, Obstetrics and Gynecology Department, Cairo University — Cairo
- Cairo University/Obstetrics and Gynecology Department/ART Unit — Cairo
Identifiers
NCT: NCT06577974 · MD-70-2023