To see various factors which help or hamper in the development of dominant follicle in females with polycystic ovarian disease with tablet Letrozole .

Assessment of various factors affecting follicular response to letrozole treatment in infertile women with polycystic ovarian syndrome - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058821

Enrollment

100

Registered

2023-10-18

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Tab Letrozole: Tablet letrozole in the dose of 2.5 mg will be started on menstrual cycle days 2-5 (post spontaneous menstruation or progesterone withdrawal bleed with Tab Medroxyprogest

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infertile women (1 year of regular unprotected intercourse without conception) 2. Age 21 to 38 years 3. Diagnosed with PCOS as per modified Rotterdam criteria (28) 4. Normal husband semen parameters as per sixth edition WHO semen analysis 2021 criteria (29) 5. At least one patent tube confirmed by hysterosalpingography/ sono-salpingography / laparoscopy 6. Not on insulin sensitizers in last 3 months 7. Willing to participate in the study and follow up

Exclusion criteria

Exclusion criteria: 1. Infertility due to causes other than anovulation 2. Endometrioma/endometriosis 3. Diminished ovarian reserve (AMH 10 IU/ml) 4. Patient with thyroid disorder, hyperprolactinemia 5. H/o laparoscopic ovarian drilling or any ovarian surgery in past 6 months 6. Females with chronic illness such as seizure disorder, diabetes mellitus, chronic kidney disease, chronic liver disease etc. 7. Any active infection such as pelvic inflammatory disease, tuberculosis, upper respiratory tract infection etc. 8. Not willing for ovulation induction

Design outcomes

Primary

Measure	Time frame
Development of at least one follicle more than 16mm diameterTimepoint: Development of at least one follicle more than 16mm diameter by day 12 of last mestrual period	—

Secondary

Measure	Time frame
1. Correlation of development of dominant follicle with clinical, endocrine, metabolic & sonographic factors among various PCOS phenotypes. 2. Incidence of luteinized unruptured follicle with letrozole therapy 3. Clinical pregnancy rate (UPT positive/presence of at least one intrauterine gestational sac in uterine cavity on ultrasonography at 5 weeks) 4. Cycle cancellation rate- No development of dominant follicle despite all protocols Timepoint: Till 3 cycles	—

Measure

Time frame

1. Correlation of development of dominant follicle with clinical, endocrine, metabolic & sonographic factors among various PCOS phenotypes. 2. Incidence of luteinized unruptured follicle with letrozole therapy 3. Clinical pregnancy rate (UPT positive/presence of at least one intrauterine gestational sac in uterine cavity on ultrasonography at 5 weeks) 4. Cycle cancellation rate- No development of dominant follicle despite all protocols Timepoint: Till 3 cycles

—

Countries

India

Contacts

Public ContactDr Shagun

All India Institute of Medical Sciences, Department of Obstetrics and Gynaecology ,New Delhi

drarchanaaiims0312@gmail.com9868308594

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026