IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

Infertility Clinical Trial

Official title:

In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02458963
• Other study ID #: AG3
• Status: Withdrawn
• Phase: Phase 4
• First received: May 28, 2015
• Last updated: May 8, 2017
• Start date: January 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Procedure:
• IVF
Women will undergo one IVF cycle

Drug:
• Gonadotropin
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol

Locations

Country	Name	City	State
Egypt	Fertility Care Unit (FCU) in Mansoura University Hospital	Mansoura	Dakahlia
Egypt	Private fertility care centers	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Number of live births divided by the number of women	9 months
Secondary	Clinical pregnancy rate	Number of clinical pregnancies divided by the number of women	6-8 weeks gestational age
Secondary	Multifetal pregnancy rate	Number of multifetal pregnancies divided by the number of clinical pregnancies	12 weeks gestational age
Secondary	Miscarriage rate	Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies	12 weeks gestational age
Secondary	Incidence of early ovarian hyperstimulation syndrome (OHSS)	Incidence of OHSS within 9 days of final triggering of oocyte maturation	Within 9 days of final triggering of oocyte maturation