Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577974
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-16
Brief Title:
Role of Medical Treatment in Endometriosis Patients Undergoing ICSI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does the Medical Tretament Prior to Stimulation Affect the Fertility Outcome in Cases of Endometriosis Associated Infertiltiy
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womans 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
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 womans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None