Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate

CMH Kharian Medical College

Status: Begins enrollment this month

Conditions: PCOS (Polycystic Ovary Syndrome)

Treatments: Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate; Drug: Letrozole (Aromatase Inhibitors)

Study type: Interventional

Funder types: Other

Identifiers

NCT07379502

CKMC/IERB/AC-00256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

letrozole

Active Comparator group

Description:

30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days

Treatment:

Drug: Letrozole (Aromatase Inhibitors)

letrozole plus estradiol valerate

Experimental group

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

Treatment:

Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate