Clinical trial · Interventional
Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
- 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)
Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.
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 |
|---|---|---|---|
| Letrozole (Aromatase Inhibitors) | Drug | Letrozole | ALIAS |
| Letrozole (Aromatase Inhibitors) + Estradiol valerate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- letrozole
- description
- 30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days
- interventionNames
- Drug: Letrozole (Aromatase Inhibitors)
- type
- EXPERIMENTAL
- label
- letrozole plus estradiol valerate
- description
- 30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days
- interventionNames
- Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate
Primary outcomes (2)
- measure
- Endometrial thickness (mm) on day of ovulation trigger
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 20-35 years * Clinical diagnosis of PCOS (Rotterdam criteria) Exclusion Criteria: * Endocrine disorders other than PCOS * Endometrial pathology or uterine malformations * Allergy to letrozole or estradiol * Hormonal therapy within last 3 months
References
Publications (0)
Data not yet available