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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Polycystic Ovary Syndrome, Infertility

Intervention / Treatment
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* Drug: Aromatase inhibitor (litrezole) plus uFSH arm
* Drug: clomiphene citrate-uFSH arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CC-plus uFSH<br>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 | Drug: clomiphene citrate-uFSH arm<br>* clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days<br>|
| Experimental: Aromataze inhibitor plus uFSH<br>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 | Drug: Aromatase inhibitor (litrezole) plus uFSH arm<br>* literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate | percentage of ovulatory cycles per started and per completed cycles | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endometrial thickness | endmetrial thickness at time of ovulation triggering | 4 weeks | 
| ongoing cycle pregnancy rate |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCOS, clomiphene citrate resistant PCOS, Aromatase inhibitors