Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

Mansoura University

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: clomiphene citrate +highly purified uFSH; Drug: clomiphene citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT01157312

MU-290s

FMH-212-G

Details and patient eligibility

About

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).

Full 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.

Enrollment: 113 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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113 participants in 2 patient groups

minimal stimulation protocol

Experimental group

Description:

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

Treatment:

Drug: clomiphene citrate +highly purified uFSH

clomiphene citrate(CC)

Active Comparator group

Description:

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

Treatment:

Drug: clomiphene citrate