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Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

Not Applicable
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
Registration Number
NCT01157312
Lead Sponsor
Mansoura University
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).

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
113
Inclusion Criteria
  • PCOS
  • No other infertility factors
  • No previous use of ovarian stimulation drugs
Exclusion Criteria
  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
minimal stimulation protocolclomiphene citrate +highly purified uFSH5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles
clomiphene citrate(CC)clomiphene citrate5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.
Primary Outcome Measures
NameTimeMethod
clinical pregnancy rate per cycle
Secondary Outcome Measures
NameTimeMethod
endometrial thickness at the time of hCG administration

Trial Locations

Locations (1)

Mansoura University Hospitals,OB/GYN department

🇪🇬

Mansoura, Dakahlia Governorate, Egypt

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