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

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Infertility
• Interventions: Drug: clomiphene citrate-uFSH arm; Drug: Aromatase inhibitor (litrezole) plus uFSH arm

• Registration Number: NCT01793038
• Lead Sponsor: Mansoura Integrated Fertility Center

Brief 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.

Study Timeline

• Study First Submitted: 2013-02-10
• Study First Submitted QC: 2013-02-13
• Study First Posted: 2013-02-15
• Status Verified: 2013-03
• Study Start: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC-plus uFSH	clomiphene citrate-uFSH arm	clomiphene citrate 50 mg tablets twice/day for cycle days 3-7 plus daily IM injection of 37.5 IU HP uFSH for days 3-12
Aromataze inhibitor plus uFSH	Aromatase inhibitor (litrezole) plus uFSH arm	Aromataze inhibitor (litrezole )2.5 mg twice daily for cycle days 3-7 plus daily IM injection of uFSH 37.5 IU for cycle days 3-12

Primary Outcome Measures

Name	Time	Method
ovulation rate	30 days	percentage of ovulatory cycles per started and per completed cycles

Secondary Outcome Measures

Name	Time	Method
endometrial thickness	4 weeks	endmetrial thickness at time of ovulation triggering
ongoing cycle pregnancy rate	16 weeks

Trial Locations

Locations (1)

Mansoura Integrated fertility center; 🇪🇬 Mansoura, Dekahlia, Egypt