Clinical trial · Interventional
Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS
Letrozole 5 mg for 10 Days Compared to Letrozole 10 mg for 5 Days for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are: What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS Participants will: The experimental arm (p1) will be treated with letrozole 5 mg for 10 days. The comparator arm (p2) will receive letrozole 10mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations. Ovarian response will be assessed by trans-vaginal monitoring of follicle growth aroundday 8 and day 11of menstrual cycle
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS (Polycystic Ovary Syndrome) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tabletrozole 10mg for 5 days | Drug | — | UNRESOLVED |
| Tab letrozole 5mg for 10 days | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm: Letrozole 5mg 10 days
- description
- Tab letrozole 5mg for 10 days from day 2-3 of menstruation/withdrawal bleeding (5mg at bed time for 10 days) for 3 cycle
- interventionNames
- Drug: Tab letrozole 5mg for 10 days
- type
- ACTIVE_COMPARATOR
- label
- Comparator arm
- description
- Tab letrozole 10mg for 5 days from day 2-3 of enstruation/withdrawal bleeding (10mg in divided dose-5mg in morning \& 5mg at bed time for 5 days) for three cycle
- interventionNames
- Drug: Tabletrozole 10mg for 5 days
Primary outcomes (2)
- measure
- • Presence of preovulatory follicle
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed cases of PCOS women according to Rotterdam criteria. * Age: 18-35 years old. * Primary or secondary infertility Exclusion Criteria: * Women withother causes of anovulation (AsCushing syndrome, late onset congenital adrenal hyperplasia, uncorrected hypothyroidism, uncorrected hyperprolactinemia). * Women with other infertility factors like tubal and uterine causes of infertility, endometriosis, undiagnosed per vaginal bleeding (From history and examination). * History of hypersensitivity to letrozole. * BMI:\< 18.5 kg/m2 and ≥30 kg/m2. * Male factor infertility. * Medical disease (uncontrolled HTN, uncontrolledDM, uncontrolledLiver disease, kidney disease).
References
Publications (2)
- RESULTGuo Z, Chen S, Chen Z, Hu P, Hao Y, Yu Q. Predictors of response to ovulation induction using letrozole in women with polycystic ovary syndrome. BMC Endocr Disord. 2023 Apr 25;23(1):90. doi: 10.1186/s12902-023-01336-z. PMID 37098539
- RESULTFranik S, Kremer JA, Nelen WL, Farquhar C. Aromatase inhibitors for subfertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2014 Feb 24;(2):CD010287. doi: 10.1002/14651858.CD010287.pub2. PMID 24563180