ClinicalTrials.Veeva

Menu

Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

M

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems