NCT01793038

Clomiphene Citrate Plus uFSH Versus Aromatase Inhibitor Plus uFSH in Clomiphene Resistant Infertile PCOS Women

Clomiphene Citrate Plus HPuFSH Versus Letrozole Plus HPuFSH in Clomid Resistant Infertile PCOS Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Mansoura Integrated Fertility Center · Academic / Other
• Sex: Female
• Age: 18 Years – 38 Years
• Healthy volunteers: Not accepted

Summary

Polycystic ovarian syndrome (PCOS) is a condition characterized by infertility, infrequent periods and amenorrhea or irregular bleeding plus anovulatory infertility. Clomid is the standard first drug of treatment for ovulation induction. Ovulation and conception will occur in approximately 75 and 30 percent of cases respectively. Cases not ovulating in response to doses of clomid up to 150 mg/day are known as clomid resistant PCOS.

Detailed description

To test whether CC co- treatment with chronic low dose HP uFSH versus lirizole plus chronic low dose HP uFSH in CC resistant PCOS will yield comparable 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.

Conditions

• Polycystic Ovary Syndrome
• Infertility

Interventions

Type	Name	Description
DRUG	Aromatase inhibitor (litrezole) plus uFSH arm	literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12
DRUG	clomiphene citrate-uFSH arm	clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-06-01
• Completion: 2014-09-01
• First posted: 2013-02-15
• Last updated: 2013-03-06

Locations

1 site across 1 country: Egypt