Clinical trial · Interventional
Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
Letrozole Step up Compared to Conventional Protocol for Ovulation Induction 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 in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. The main Questions it aims to answer are: * Does drug letrozole in step up dose result in better ovarian response? * What medical problems do participants have when taking drug letrozole in step up dose? Researchers will compare drug letrozole step up dose to a standard low dose to see if the step up dose works to achieve better ovarian response. Participants will: * Take drug letrozole step up or standard low dose from day 2 of menstruation for 3 cycles * Visit the clinic on day 12-16 of menstural cycle for checkups and tests * Keep a diary of any untoward symptoms
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Infertility | — | UNRESOLVED | — |
| Polycystic Ovarian Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional fixed dose letrozole | Drug | — | UNRESOLVED |
| Letrozol step up dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Letrozole step up
- description
- Tab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
- interventionNames
- Drug: Letrozol step up dose
- type
- ACTIVE_COMPARATOR
- label
- Conventional fixed dose letrozole
- description
- Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
- interventionNames
- Drug: Conventional fixed dose letrozole
Primary outcomes (2)
- measure
- The number of participants having mature follicle (mean diameter ≥18mm)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * PCOS women with subfertility * Selected for ovulation induction Exclusion Criteria: * Body mass index (BMI) ˂18 and ≥30 kg/m2, * Women with other infertility factors (endometriosis, suspected tubal factor, and uterine causes of infertility) * Male factor infertility
References
Publications (1)
- BACKGROUNDKaur J, Suri V, Gainder S, Arora A. Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility. Arch Gynecol Obstet. 2019 Dec;300(6):1767-1771. doi: 10.1007/s00404-019-05326-2. Epub 2019 Oct 20. PMID 31631248