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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Those treated by COCPs before IVSI | Experimental | Those with endometrisosis who will undergo ICSI after pretreatment with COCPs |
|
| Those treated by Dionogest before ICSI | Experimental | Patients diagnosed with endometriosis who will undergo ICSI after oreteatment by dienogest |
|
| Those undergoing ICSI straighaway | No Intervention | patients diagnosed with endometriosis who will undergo ICSI without any medical pretretament |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined contraceptive pills (Yasmin) | Drug | medical pretreatment prior to ICSI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fertilisation rate | Number of embryos | 2 weeks from starting induction |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | appearance of intrauterine gestational sac | 2 weeks from embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariam Dawoud, A. Professor | Contact | 01157355666 | zdawoud9@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Taha, Professor | Cairo University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ART unit, Obstetrics and Gynecology Department, Cairo University | Recruiting | Cairo | Egypt |
Study protocol, excel sheet
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| C023635 | dienogest |
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|
| Cairo University/Obstetrics and Gynecology Department/ART Unit | Recruiting | Cairo | Egypt |
|
| D000091662 | Genital Diseases |