NCT Number: NCT07379502
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.
Trial opening soon.
Get Notified20 year–35 year
Female
Interventional
Not applicable
Khārian, Punjab Province, 50070, Pakistan
Maryum Noor Malik, MBBS, FCPS, CHPE
CONTACT
Maryum Noor Malik, MBBS, FCPS, CHPE
PRINCIPAL_INVESTIGATOR
Mugheera Hussain, MBBS, FCPS, MRCPI
SUB_INVESTIGATOR
Mushayada Irshad, MBBS, Mphil, CHPE
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days
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
Time frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial thickness will be measured on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle.
Time frame: 12th day of cycle 1 (Each cycle is 28 days)
Endometrial pattern will be seen on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle
Contact information is provided by the study sponsor or research team.
Maryum Noor Malik, MBBS, FCPS, CHPE
CONTACT
Mushayada Irshad, MBBS, Mphil, CHPE
CONTACT
CMH Kharian Medical College
Other Gov
Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
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