Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT01157312

Collaborator

(none)

113

Enrollment

Location

Arms

Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: clomiphene citrate +highly purified uFSH Drug: clomiphene citrate	N/A

Detailed Description

All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

Study Design

Study Type:

Interventional

Actual Enrollment :

113 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: minimal stimulation protocol 5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles	Drug: clomiphene citrate +highly purified uFSH
Active Comparator: clomiphene citrate(CC) 5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.	Drug: clomiphene citrate

Arm

Intervention/Treatment

Experimental: minimal stimulation protocol

5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles

Drug: clomiphene citrate +highly purified uFSH

Active Comparator: clomiphene citrate(CC)

5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.

Drug: clomiphene citrate

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate per cycle []

Secondary Outcome Measures

endometrial thickness at the time of hCG administration []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

PCOS
No other infertility factors
No previous use of ovarian stimulation drugs

Exclusion Criteria:

Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospitals,OB/GYN department	Mansoura	Dakahlia Governorate	Egypt

Sponsors and Collaborators

Mansoura University

Investigators

Principal Investigator: Hatem Abu Hashim, MD MRCOG, Mansoura University Hospital
Study Director: Mohamed F Bazeed, MD, Mansoura University Hospital
Study Chair: Ibrahim Abd Elaal, MD, Mansoura University Hospital