IVF Versus LOD in Women With CC Resistant PCOS

Sponsor

Mohamed Sayed Abdelhafez (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02456792

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility Polycystic Ovarian Syndrome	Procedure: IVF Procedure: LOD	Phase 4

Detailed Description

Women will be randomly divided into two groups; IVF group and LOD group. Women in the IVF group will undergo one full IVF cycle. Women in the LOD group will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

In Vitro Fertilization Versus Laparoscopic Ovarian Drilling in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Apr 1, 2017

Anticipated Study Completion Date :

May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IVF group Women will undergo one full IVF cycle	Procedure: IVF Women will undergo one IVF cycle Other Names: Intracytoplasmic sperm injection (ICSI)
Active Comparator: LOD group Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months	Procedure: LOD Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months Other Names: Laparoscopic ovarian diathermy

Arm

Intervention/Treatment

Active Comparator: IVF group

Women will undergo one full IVF cycle

Procedure: IVF

Women will undergo one IVF cycle

Other Names:

Intracytoplasmic sperm injection (ICSI)

Active Comparator: LOD group

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Procedure: LOD

Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months

Other Names:

Laparoscopic ovarian diathermy

Outcome Measures

Primary Outcome Measures

Live birth rate [9 months]
Number of live births divided by the number of women

Secondary Outcome Measures

Clinical pregnancy rate [6-8 weeks gestational age]
Number of clinical pregnancies divided by the number of women
Multifetal pregnancy rate [12 weeks gestational age]
Number of multifetal pregnancies divided by the number of clinical pregnancies
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.