Ignite Creation Date:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2026-01-01 @ 7:05 AM
Study NCT ID:
NCT03881904
Status:
UNKNOWN
Last Update Posted:
2019-03-20
First Post:
2019-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OCP Pretreatment in PCOS Patients Undergoing ICSI Using Antagonist Protocol
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Oral Contraceptive Pill Pretreatment in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Using the Gonadotrophin Releasing Hormone Antagonist Protocol (A Randomized Controlled Trial)
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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:
373 women with PCOS undergoing a trial of IVF/ICSI will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment.
Both groups will be followed up for effect on ongoing pregnancy rate.
Another 373 women with PCOS undergoing a trial of IVF/ICSI will start GnRH antagonist COH directly without OCP pretreatment.
Both groups will be followed up for effect on ongoing pregnancy rate.
Detailed Description:
The study will include 740 women with polycystic ovary syndrome undergoing IVF/ICSI cycle using flexible antagonist protocol.
Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups.
Study Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Control Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment.
Random allocation sequence generation:
A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups.
Primary outcome will be ongoing pregnancy rate.
Secondary outcomes will be biochemical and clinical pregnancy rates.
Randomization:
Patients fulfilling the inclusion criteria will be randomized to two groups.
Study Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will receive OCP from day 2 of the preceding cycle for 21 days followed by GnRH antagonist COH.
Control Group:
This group will include 373 women with PCOS undergoing a trial of IVF/ICSI. This group will start GnRH antagonist COH directly without OCP pretreatment.
Random allocation sequence generation:
A computer generated list via MedCalc ® Software, version 13.2.2 will be used, assigning each participant number to either study groups.
Allocation Concealment:
Assignment will be done by sequentially numbered, otherwise identical, sealed envelopes (SNOSE), each containing a 2-inch by 2-inch paper with a written code designating the assigned group. These papers will be placed in a folded sheet of aluminum foil fitted inside the envelope. Effort will be taken to assure absence of any detectable differences in size or weight between intervention and control envelopes. Envelopes will be chosen to be opaque and lined inside with carbon paper. Envelopes will be opened sequentially only after writing the subject's tracking information on the envelope so that the carbon paper served as an audit trail.
IVF/ICSI cycle will be done using flexible anatgonist protocol in both groups.
Primary outcome will be ongoing pregnancy rate.
Secondary outcomes will be biochemical and clinical pregnancy rates.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: