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The effect of Letrozole on pregnancy rate in women with polycystic ovary syndrome

Investigating the effect of repeated Letrozole doses on mature follicles status and pregnancy rate in women with polycystic ovary syndrome resistant to the initial Dose: a randomized controlled trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20081007001306N12
Enrollment
124
Registered
2024-06-13
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Female infertility. Female infertility

Interventions

Intervention 1: Control group:Eligible infertile women with polycystic ovary syndrome, referring to one of the private clinics in Rasht, who will be treated with letrozole in a dose of 5 mg/for 5 days

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 35 Years

Inclusion criteria

Inclusion criteria: All infertile women with polycystic ovary syndrome resistant to letrozole primary treatment With full consent to participate in the study Under the age of 35 There is an indication for the use of oral medication (not received 6 cycles of ovulation induction medication)

Exclusion criteria

Exclusion criteria: Obstruction of the fallopian tubes Absence of a healthy uterine cavity Ovarian cysts Metabolic diseases and any disease that has a negative effect on ovulation Chronic heart, liver and kidney diseases Abnormal sperm analysis Using other ovulation induction drugs at the same time

Design outcomes

Primary

MeasureTime frame
The size of mature follicle equal to 17 mm in sonographic evaluation. Timepoint: On day 22-23 of the cycle. Method of measurement: By transvaginal ultrasound.

Secondary

MeasureTime frame
Biochemical pregnancy rate. Timepoint: 2-3 weeks after seeing the mature follicle. Method of measurement: through laboratory measurement (BhCG level).;Clinical pregnancy. Timepoint: in 6-7 weeks of pregnancy. Method of measurement: Observation of fetal heartbeat in sonographic evaluation.;Early pregnancy failure(Ioss of pregnancy products before week12). Timepoint: Before week 12. Method of measurement: By transvaginal ultrasound.;Multiple pregnancy (seeing two or more gestational sacs and fetal heart rate in them. Timepoint: In 6-7 weeks of pregnancy. Method of measurement: By transvaginal ultrasound.;Ectopic pregnancy (implantation somewhere other than inside the uterine cavity). Timepoint: In week 5-7. Method of measurement: By transvaginal ultrasound.;Side effects of letrozole include: bone pain, fatigue, nausea, night sweats, hot flashes, headache and dizziness. Timepoint: At any time during the study process. Method of measurement: It is checked by a questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ziba Zahiri Sorouri

Rasht University of Medical Sciences

zibazahiri@yahoo.com+98 13 3336 9224

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026