Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letrozole (Aromatase Inhibitors), Letrozole (Aromatase Inhibitors) + Estradiol valerate.
- Who it may be relevant to
- Registry conditions: PCOS (Polycystic Ovary Syndrome). Basic parameters: 20 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
Overview
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.
Interventions
- 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
Primary outcome measures
- Endometrial thickness (mm) on day of ovulation trigger [Time frame: 12th day of cycle 1 (Each cycle is 28 days)]
- Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger [Time frame: 12th day of cycle 1 (Each cycle is 28 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- CMH Kharian Medical College — Khārian
Identifiers
NCT: NCT07379502 · CKMC/IERB/AC-00256