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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01793038

Enrollment

160

Registered

2013-02-15

Start date

2013-03-31

Completion date

2014-09-30

Last updated

2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Polycystic Ovary Syndrome

Keywords

PCOS, clomiphene citrate resistant PCOS, Aromatase inhibitors

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.

Interventions

DRUGAromatase 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

DRUGclomiphene citrate-uFSH arm

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

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

Design outcomes

Primary

Measure	Time frame	Description
ovulation rate	30 days	percentage of ovulatory cycles per started and per completed cycles

Secondary

Measure	Time frame	Description
endometrial thickness	4 weeks	endmetrial thickness at time of ovulation triggering
ongoing cycle pregnancy rate	16 weeks	—

Countries

Egypt

Contacts

Primary Contactmohamad E GHanem, MD

meghanem87@gmail.com00201223366955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026