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Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS

NCT01212263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2013-05-30

No results posted yet for this study

Summary

To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Step-up HP u FSH

HP u FSH (Fostimone 75 IU ,IBSA Institut Biochimique SA-CH 6903 Lugano) in doses of 37.5 IU (half ampole) im /day statrted from second day of the cycle for 7 days ,then increased to 75 IU for another 7 days ,then to 112.5 IU (one and half ampoule) untilleading follicle mean diameter reaches 18 mm

DRUG

Clomiphine citrate plus low dose uFSH

Clomiphene citrate 50 mg tab oral tablets(Clomid 50 mg tablets Global Napi , Egypt) two tablets(100 mg) /day are started from the 2nd day of cycle for 5 days togeteher with 37.5 IU HP uFSH (Fostimone 75 IU IBSA)/day for 8 days and may be extended to 10-12 days until leading follicle diameter reaches 18 mm

Sponsors & Collaborators

  • Mansoura Integrated Fertility Center

    lead OTHER

Principal Investigators

  • Mohamad E Ghanem, MD · Mansoura Integrated Fertility Center

  • Mohammad A Emam, MD · Mansoura Integrated Fertility Center

  • Mohamad E Ghanem, MD · Mansoura Integrated Fertility Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-09-30
Completion
2012-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212263 on ClinicalTrials.gov