Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Conditions
Keywords
Letrozole, Estradiol Valerate, Endometrial response, Endometrial thickness, Polyendocrine Metabolic Ovarian Syndrome (PMOS)
Brief summary
Polyendocrine Metabolic Ovarian Syndrome (PMOS) 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
Polyendocrine Metabolic Ovarian Syndrome (PMOS) 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
30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days
DRUGLetrozole (Aromatase Inhibitors) + Estradiol valerate
30 participants with PMOS will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days
Sponsors
CMH Kharian Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 20-35 years * Clinical diagnosis of PMOS (Rotterdam criteria)
Exclusion criteria
* Endocrine disorders other than PMOS * Endometrial pathology or uterine malformations * Allergy to letrozole or estradiol * Hormonal therapy within last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness (mm) on day of ovulation trigger | 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. |
| Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger | 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 |
Countries
Pakistan
Outcome results
None listed