Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: T.Letrozole 2.5 mg OD for 10 days: Group 2 (Case Group A): Low-dose, long-duration Letrozole 2.5 mg for 10 days (Cycle Days 2-11). Ovulation is assessed after the first cycle of treatme
Sponsors
All India Institute of Medical Sciences,New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. Normal husband semen parameters as per the sixth edition WHO semen analysis 2021 criteria. 3. Patient with at least one tube patent as confirmed by hysterosalpingography.
Exclusion criteria
Exclusion criteria: 1. Patients younger than 21 years and older than 38 years. 2. Patient with a history of endometriosis. 3. 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). 4. Patient with uncontrolled thyroid disorders. 5. Patient with abnormal prolactin levels. 6. Patient with prior ovarian surgery. 7. Patient who has used any hormonal contraception or insulin sensitizers in the last three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful ovulatory response as determined by disappearance of dominant follicle on USGTimepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Number of different sizes of dominant follicles developed in each group. 2. Time to ovulation. 3.Maximum follicle size before rupture. 4. Endometrial thickness at the time of ovulation. 5.Need for Injection Gonadotropin. 6.Ovarian hyperstimulation syndrome rate (OHSS). 7.Clinical pregnancy rate. 8. Rate of multiple pregnancies. 9.Cycle cancellation rate. 10. Abortion rate. 11.Side effects like nausea, vomiting & any other drug reactions.Timepoint: 1.On each follicular scan(Day 11 till ovulation) 2.From start of treatment to ovulation,per cycle 3.On last scan before rupture/ovulation 4.On last scan before follicle rupture 5.Recorded per cycle if given for ovulation trigger 6.Upto 2 weeks post-ovulation 7.UPT test if missed periods after 2 weeks 8.On early pregnancy USG (6 10 weeks gestation) 9.Documented per cycle due to non-response or complications 10.Recorded through first trimester follow-up 11.Monitored throughout each treatment cycle | — |
Countries
India
Contacts
Public ContactArchana Kumari
All India Institute of Medical Sciences, Delhi
Outcome results
None listed