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

Mansoura Integrated Fertility Center

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Clomiphine citrate plus low dose uFSH; Drug: Step-up HP u FSH

Study type: Interventional

Funder types: Other

Identifiers

NCT01212263

MansouraIFC1

Details and patient eligibility

About

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.

Full description

To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.

Enrollment: 174 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CC resistant PCOS
• Infertile
• Females
• Age 18-38

Exclusion criteria

• Hyperprolactinaemia
• Cushing syndrome
• Adult onset adrenal hyperplasia
• Age >38
• Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Clomiphene Citrate plus HP uFSH

Experimental group

Description:

Starting from the 2nd day of the cycle Clomiphene Citrate( CC)50 mg tablets are given in 100 mg daily dose for 5 days together with an low dose HP uFSH (half ampoule: 37.5 IU) given im daily for 8-10 days.

Treatment:

Drug: Clomiphine citrate plus low dose uFSH

Step-up HP uFSH

Active Comparator group

Description:

HP uFSH started in doses of half ampole (37.5 )IU daily from the 2nd day of cycle for 7 days ,then dose is stepped-up to one ampoule ( 75 IU) for 7 days then the one and a half amps (112.5) IU /day until follicular diameter reaches 18 mm mean diameter

Treatment:

Drug: Step-up HP u FSH