Optimal dose and duration of Letrozole for ovulation induction in infertile women with Polycystic Ovarian Syndrome : A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Successful ovulatory response as determined by disappearance of dominant follicle on USG
研究概览
简要总结
Thesis Protocol Summary
Title: Optimal Dose and Duration of Letrozole for Ovulation Induction in Infertile Women with PCOS
Study Design
A prospective interventional study comparing three different Letrozole regimens for ovulation induction in women with polycystic ovary syndrome (PCOS).
Study Groups
-
Group 1 (Control): Letrozole 5 mg for 5 days (Day 2-6)
-
Group 2 (Case A): Letrozole 2.5 mg for 10 days (Day 2-11)
-
Group 3 (Case B): Letrozole 5 mg for 10 days (Day 2-11)
Treatment Protocol
Maximum 3 cycles of Letrozole treatment.
If no ovulation after 1 cycle, dose modification will be done.
If ovulation is not achieved after 3 cycles, the patient will be switched to gonadotropin injections (HMG 75/150 IU IM).
If still unresponsive, management will follow hospital protocol (e.g., laparoscopic ovarian drilling or IVF).
Inclusion Criteria
Women aged 21-38 years with PCOS diagnosed by Modified Rotterdam Criteria (at least 2 out of 3):
Oligo/anovulation (cycle length >35 days)
Clinical/biochemical hyperandrogenism (mFG score >8, serum testosterone ≥0.56 ng/ml)
Polycystic ovaries on ultrasound (FNPO ≥20, ovarian volume >10 cc)
Normal husband semen parameters (as per WHO 2021 criteria).
At least one patent fallopian tube confirmed by hysterosalpingography.
Exclusion Criteria
Age <21 or >38 years
Endometriosis or prior ovarian surgery
Diminished ovarian reserve (AMH <1.5 ng/ml, AFC <7, FSH >10 IU/ml)
Uncontrolled thyroid disorders or abnormal prolactin levels
Use of hormonal contraception or insulin sensitizers in the past 3 months
The cost of Letrozole is covered by the institution.
2 ml blood will be taken for baseline investigations.
This study aims to determine the most effective Letrozole regimen for ovulation induction in PCOS patients, optimizing both dose and duration to improve pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 38.00 Year(s)（—）
- 性别
- Female
入选标准
- •Any patient from 21 to 38 years attending Gynecology OPD with features of PCOS as per Modified Rotterdam criteria, which includes at least two out of the following three features: Oligo or anovulation (menstrual cycle length greater than 35 years) Clinical and or ovarian biochemical evidence of hyperandrogenism (mFG score greater than eight; serum testosterone greater than or equal to 0.56 nanograms per milliliter).
- •FNPO greater than or equal to 20 and ovarian volume greater than 10 cubic centimeters in transvaginal scan done on day two.
- •Normal husband semen parameters as per the sixth edition WHO semen analysis 2021 criteria.
- •Patient with at least one tube patent as confirmed by hysterosalpingography.
排除标准
- •Patients younger than 21 years and older than 38 years.
- •Patient with a history of endometriosis.
- •Patient with diminished ovarian reserve (AMH less than 1.5 nanograms per milliliter, AFC less than seven, FSH greater than 10 international units per milliliter).
- •Patient with uncontrolled thyroid disorders.
- •Patient with abnormal prolactin levels.
- •Patient with prior ovarian surgery.
- •Patient who has used any hormonal contraception or insulin sensitizers in the last three months.
结局指标
主要结局
Successful ovulatory response as determined by disappearance of dominant follicle on USG
时间窗: To assess response, follicular phase ultrasound will be performed | on day 11 of the cycle. Follicular monitoring will continue every | alternate day till a Dominant follicle of size more than 16 mm is formed. | Timed intercourse will be advised. | Response to treatment implies disappearance of at least one | dominant follicle more than 16 mm diameter or appearance of corpus luteal | cyst
次要结局
- 1.Number of different sizes of dominant follicles developed in each group.(2. Time to ovulation.)
研究者
Archana Kumari
All India Institute of Medical Sciences, Delhi