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

Sponsor

Mansoura Integrated Fertility Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01793038

Collaborator

(none)

160

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome Infertility	Drug: Aromatase inhibitor (litrezole) plus uFSH arm Drug: clomiphene citrate-uFSH arm	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CC-plus uFSH 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 clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days
Experimental: Aromataze inhibitor plus uFSH 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 literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12

Arm

Intervention/Treatment

Active Comparator: CC-plus uFSH

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

clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days

Experimental: Aromataze inhibitor plus uFSH

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

literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12

Outcome Measures

Primary Outcome Measures

ovulation rate [30 days]
percentage of ovulatory cycles per started and per completed cycles

Secondary Outcome Measures

endometrial thickness [4 weeks]
endmetrial thickness at time of ovulation triggering
ongoing cycle pregnancy rate [16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 38 Years

Sexes Eligible for Study:

Female

Accepts 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