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

M

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)

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

Trial contacts and locations

1

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Central trial contact

mohamad E GHanem, MD

Data sourced from clinicaltrials.gov

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