Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04600986
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-10-19
Brief Title:
Repeated Doses of GnRH Agonist as Oocyte Triggering in Antagonist Protocol for Patients With Polycystic Ovary Syndrome
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
The Effect of Repeated Doses of a GnRH Agonist on Oocyte Triggering in Antagonist Protocol for Patients With Polycystic Ovary Syndrome a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective randomized proof-of-concept study designed to compare the IVF results in patients diagnosed with polycystic ovarian syndrome PCOS defined as per the ESHREASRM Rotterdam criteria 2003 undergoing in-vitro fertilization intracytoplasmic sperm injection IVFICSI in antagonist protocol Patients were randomized into two groups Group A single dose of GnRHa 02 mg 35 h prior to oocyte retrieval and Group B 02 mg GnRHa 35 h prior to oocyte retrieval a repeat dose of 01 mg 12 h following the 1st dose 12 h post-trigger luteinizing hormone LH progesterone P4 values will be estimated
Detailed Description:
The aim of this study was to establish if a second dose of GnRHa repeated 12 h following the initial dose optimizes the cycle outcome in terms of oocyte maturity in women with PCOS of Asian origin
The study was approved by the institutional review board and written informed consent will be obtained from each participant Infertile women with a diagnosis of PCOS who undergo the IVF ICSI cycle are assigned to two groups randomly The random method is that the statistician will be provided a blocked randomization list for the number of patientsand whenever an eligible patient is referred a sealed envelope will be delivered to the clinical physician The random allocation is concealed from the physician performing the IVFICSI treatment cycle All patients will receive antagonist controlled ovarian stimulation protocol with same starting dose of gonadotropin On the day of trigger serum E2 LH and P4 concentrations will be measured When three lead follicles achieved 17-mm diameter in group A the final oocyte maturation will be triggered with a single dose of 02 mg sc triptorelin decapeptyl 35 h prior to oocyte retrieval in both the groups and in Group B a repeat dose of 01 mg 12 h following the first dose Post-trigger LH and progesterone levels will be measured 12 h following the first dose of GnRHa and ovum-pick up day Transvaginal ultrasound-guided oocyte pickup OPU will be performed 35 h following the first dose under intravenous sedation with single-lumen oocyte retrieval needle Post pickup on days 4 and 7 an assessment for symptoms and signs of OHSS and patients will be advised to present at any time within 2 weeks of GnRHa administration
In all subjects IVF or ICSI will be performed according to the standard operating procedure The fertilization will be assessed 18 h following ICSI or IVF by the appearance of two pronuclei All embryos will be cryopreserved by vitrification in the form of blastocyst The frozen embryo transfer FET cycles will be performed following pretreatment with oral contraceptive pills in an artificial cycle with a daily dose of orally administered 6 mg of estradiol When the endometrium evaluated by TVS was 8 mm with triple-layer morphology it is considered mature This will be followed by endometrial priming with 5 days of injectable progesterone for blastocysts The transfer will be performed using Sure-Pro Ultra catheter Luteal-phase supplementation will be continued with vaginal progesterone and estradiol for 14 days and when pregnancy will be achieved till 10 weeks of gestation
The primary outcome will be the maturity rate of the oocytes the ratio of MII oocytes to the total number of oocytes retrieved and oocyte yield The secondary outcomes are fertilization rate number and quality of blastocyst embryos OHSS occurrence and post-trigger serum LH IUL and P4 ngmL levels In addition implantation and clinical pregnancy rates will be also evaluated Data collection will be performed by using questionnaires to be filled as per the available records and laboratory results Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 20 for windows
The study was approved by the institutional review board and written informed consent will be obtained from each participant Infertile women with a diagnosis of PCOS who undergo the IVF ICSI cycle are assigned to two groups randomly The random method is that the statistician will be provided a blocked randomization list for the number of patientsand whenever an eligible patient is referred a sealed envelope will be delivered to the clinical physician The random allocation is concealed from the physician performing the IVFICSI treatment cycle All patients will receive antagonist controlled ovarian stimulation protocol with same starting dose of gonadotropin On the day of trigger serum E2 LH and P4 concentrations will be measured When three lead follicles achieved 17-mm diameter in group A the final oocyte maturation will be triggered with a single dose of 02 mg sc triptorelin decapeptyl 35 h prior to oocyte retrieval in both the groups and in Group B a repeat dose of 01 mg 12 h following the first dose Post-trigger LH and progesterone levels will be measured 12 h following the first dose of GnRHa and ovum-pick up day Transvaginal ultrasound-guided oocyte pickup OPU will be performed 35 h following the first dose under intravenous sedation with single-lumen oocyte retrieval needle Post pickup on days 4 and 7 an assessment for symptoms and signs of OHSS and patients will be advised to present at any time within 2 weeks of GnRHa administration
In all subjects IVF or ICSI will be performed according to the standard operating procedure The fertilization will be assessed 18 h following ICSI or IVF by the appearance of two pronuclei All embryos will be cryopreserved by vitrification in the form of blastocyst The frozen embryo transfer FET cycles will be performed following pretreatment with oral contraceptive pills in an artificial cycle with a daily dose of orally administered 6 mg of estradiol When the endometrium evaluated by TVS was 8 mm with triple-layer morphology it is considered mature This will be followed by endometrial priming with 5 days of injectable progesterone for blastocysts The transfer will be performed using Sure-Pro Ultra catheter Luteal-phase supplementation will be continued with vaginal progesterone and estradiol for 14 days and when pregnancy will be achieved till 10 weeks of gestation
The primary outcome will be the maturity rate of the oocytes the ratio of MII oocytes to the total number of oocytes retrieved and oocyte yield The secondary outcomes are fertilization rate number and quality of blastocyst embryos OHSS occurrence and post-trigger serum LH IUL and P4 ngmL levels In addition implantation and clinical pregnancy rates will be also evaluated Data collection will be performed by using questionnaires to be filled as per the available records and laboratory results Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 20 for windows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None