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

Mansoura Integrated Fertility Center

Status: Unknown

Conditions: Infertility; Polycystic Ovary Syndrome

Treatments: Drug: clomiphene citrate-uFSH arm; Drug: Aromatase inhibitor (litrezole) plus uFSH arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01793038

Mific-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated 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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160 participants in 2 patient groups

CC-plus uFSH

Active Comparator group

Description:

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

Treatment:

Drug: clomiphene citrate-uFSH arm

Aromataze inhibitor plus uFSH

Experimental group

Description:

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

Treatment:

Drug: Aromatase inhibitor (litrezole) plus uFSH arm