IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

Phase 4

Withdrawn

• Conditions: Polycystic Ovarian Syndrome; Infertility
• Interventions: Procedure: IVF; Drug: Gonadotropin

• Registration Number: NCT02458963
• Lead Sponsor: Mohamed Sayed Abdelhafez

Brief Summary

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Detailed Description

Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Study Timeline

• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-01
• Study Start: 2016-01
• Primary Completion: 2017-04
• Status Verified: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Infertile women with PCOS as defined by the Rotterdam criteria.
• CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria

• Age < 20 or > 35 years.
• Presence of any infertility factor other than anovulatory PCOS.
• Previous history of ovarian surgery or surgical removal of one ovary.
• Previous exposure to cytotoxic drugs or pelvic irradiation.
• Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
• Metabolic or hormonal abnormalities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVF group	IVF	Women will undergo one full IVF cycle
Gonadotropin group	Gonadotropin	Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Primary Outcome Measures

Name	Time	Method
Live birth rate	9 months	Number of live births divided by the number of women

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6-8 weeks gestational age	Number of clinical pregnancies divided by the number of women
Miscarriage rate	12 weeks gestational age	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Incidence of early ovarian hyperstimulation syndrome (OHSS)	Within 9 days of final triggering of oocyte maturation	Incidence of OHSS within 9 days of final triggering of oocyte maturation
Multifetal pregnancy rate	12 weeks gestational age	Number of multifetal pregnancies divided by the number of clinical pregnancies

Trial Locations

Locations (2)

Fertility Care Unit (FCU) in Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt

Private fertility care centers; 🇪🇬 Mansoura, Dakahlia, Egypt