Comparison of the effect of letrozole initiation on ovulation on the cycle day 3 with cycle day 5 in polycystic ovary syndrom patients

A randomized clinical trial on comparing the effect of initiation of letrozole on cycle day 3 with cycle day 5 on ovulation in patients with clomiphene citrate-resistant polycystic ovary syndrom.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201307096467N3

Enrollment

Registered

2014-03-21

Start date

2010-03-01

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Control group: Letrozole, 3 mg, from third day of cycle for 5 days. Intervention 2: Intervention group: Letrozole, 3 mg, from fifth day of cycle for 5 days.

Treatment - Drugs

Control group: Letrozole, 3 mg, from third day of cycle for 5 days

Intervention group: Letrozole, 3 mg, from fifth day of cycle for 5 days

Eligibility

Sex/Gender

Female

Age

20 Years to 30 Years

Inclusion criteria

Inclusion criteria: The main inclusion criteria to study: women with previously diagnosed polycystic ovary syndrome (PCOS) and infertility according to ?Rotterdam criteria; Age between 20-30 years; No previous history of ovarian surgery; Women ?who did not ovulate on clomiphene citrate in at least 3 previous cycles (did not attain at least 1 ?follicle equal or more than 18mm on ultrasound scan). The main exclusion criteria from study: Women with infertility of any ?other etiology; Exposure to cytotoxic drugs; Pelvic radiation therapy?

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Follicle equal or more than 18mm. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Vaginal ultrasonography.;Endometrial thickness ?. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Vaginal ultrasonography.;Testosterone Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.;Androstendione Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.;Estradiol Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.	—

Measure

Time frame

Follicle equal or more than 18mm. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Vaginal ultrasonography.;Endometrial thickness ?. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Vaginal ultrasonography.;Testosterone Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.;Androstendione Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.;Estradiol Hormone. Timepoint: Before the first dose of letrozole? and 3 days after the last dose of letrozole dose. Method of measurement: Blood test.

—

Secondary

Measure	Time frame
Pregnancy. Timepoint: At the end of Menstrual cycle. Method of measurement: BHCG test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNayereh Ghomian

Imam Reza Hospital

ghomiann@mums.ac.ir+98 51 1802 2608

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 5, 2026