study to assess efficacy of extended regimen of letrozole in infertile women with polycystic ovarian syndrome

Phase 2/3

Not yet recruiting

Conditions: Female infertility associated withanovulation, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,

Registration Number: CTRI/2023/10/059166

Lead Sponsor: AIIMS NEW DELHI

Brief Summary: Polycystic ovary syndrome (PCOS) is a complex condition in women associated with psychological, reproductive and metabolic features. PCOS is the most common hormonal disorder in women and accounts for ~80% of women with anovulatory infertility. A large subset of patients with chronic anovulation are unable to conceive and seek treatment for infertility. Ovulation induction therapy is the treatment of choice for such patients. Letrozole, a highly selective aromatase inhibitor (AI), has been found to be effective in inducing ovulation in anovulatory and ovulatory infertile women with inadequate response to clomiphene citrate (CC). Letrozole is typically prescribed at a starting dose of 2.5 mg or 5 mg daily for 5 days. Women with PCOS who do not ovulate or become pregnant with letrozole may be candidates for therapy with injectable gonadotropins. Advantages of AIs include that they can be orally administered with almost 100% bioavailability, have rapid clearance from the body (short half-life, â‰ˆ45 hours), well tolerated on daily administration and have no adverse effect on endometrium or cervical mucus. Moreover, the disadvantages of gonadotropins are injectable preparation, thus uncomfortable for the patient, require a health professional and multiple hospital visits for administration, have higher costs for ovulation induction along with increased risk of OHSS. Extending the duration of letrozole treatment in the mid follicular phase would maintain FSH levels above the threshold allowing multi follicular development and larger size dominant and mature follicles. Looking at the advantages and the mechanism by which letrozole works in ovulation induction, letrozole alone treatment has been tried with different doses. However there has been very few studies assessing the optimum duration of letrozole therapy. Thus the purpose of this study is to assess the response of extended letrozole regimen compared to standard letrozole regimen in infertile women with PCOS undergoing ovulation induction.

**AIM**: To assess the response to extended regimen of letrozole in comparison to standard letrozole regimen in infertile women with PCOS undergoing ovulation induction.

**HYPOTHESIS:**Extended letrozole therapy might result in better ovulatory response than standard letrozole therapy in infertile women with PCOS.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 80

Inclusion Criteria

Any patient from 21-38 years attending gynaecology OPD with features of PCOS as per modified Rotterdam criteria i.e. with 2/3 features: Oligo/anovulation, clinical and/or biochemical evidence of hyperandrogenism Normal husband semen parameters as per sixth edition WHO semen analysis 2021 criteria.
Patient with at least one patent fallopian tube confirmed by hysterosalpingography or laparoscopy.
Patient with controlled thyroid disorders.
Patient with normal prolactin levels.
Patient with no ovarian surgery.
Patient who are not on any hormonal contraception or insulin sensitizers in last 3 months.

Exclusion Criteria

Patients less than 21 years and more than 38 years.
Patient with history of endometriosis.
Patient with diminished ovarian reserve (AMH <1.5 ng/ml, AFC<7, FSH>10 IU/ml).
Patient with uncontrolled thyroid disorder.
Patient with hyperprolactinemia.
Patient with non-classical congenital adrenal hyperplasia.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of at least one follicle 16mm diameter with ovulation induction cycle by extended letrozole regimen as well as the standard regimen	18 days

Secondary Outcome Measures

Name	Time	Method
Number of different sizes of dominant follicles developed in each group.	To correlate S.AMH levels with follicular response in both groups.

Trial Locations

Locations (1): AIIMS NEW DELHI
🇮🇳
South, DELHI, India
AIIMS NEW DELHI
🇮🇳South, DELHI, India
Bhavneet Kaur
Principal investigator
9888704201
bhavneetkaur201@gmail.com