NCT07379502

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CMH Kharian Medical College · Other Government
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. However, one of the drawbacks of aromatase inhibitors is suboptimal endometrial development, which may adversely affect implantation and pregnancy outcomes. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. Limited data exist on whether adding estradiol to letrozole truly improves the endometrial response and clinical pregnancy rates in women with PCOS. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.

Conditions

• PCOS (Polycystic Ovary Syndrome)

Interventions

Type	Name	Description
DRUG	Letrozole (Aromatase Inhibitors)	30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days
DRUG	Letrozole (Aromatase Inhibitors) + Estradiol valerate	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

Timeline

• Start date: 2026-03-05
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Pakistan