Health Condition 1: N970- Female infertility associated withanovulation Health Condition 2: Z331- Pregnant state, incidental
Conditions
Interventions
Intervention1: Letrozole plus clomiphene citrate: Women will receive a combination of 2.5 mg letrozole daily and 50 mg clomiphene citrate on day 3-7 of cycle
Control Intervention1: Letrozole: Women wi
Sponsors
Dr Komal
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 18-40 years diagnosed with PCOS based on Rotterdam criteria(must meet 2 out of 3) -Oligo/anovulation -Clinical and/or biochemical signs of hyperandrogenism -Polycystic ovaries on ultrasound (more than 12 follicles in ovary 2-Infertility for at least 12 months 3-Normal semen analysisnof male partner 4-Willlingness to provide informed consent
Exclusion criteria
Exclusion criteria: 1-Pregnancy 2-Current hormonal contraception use 3-Uncorrected thyroid disease 4-Untreated hyperprolactinemia 5-Uncontrolled type1 and 2 DM 6-Hypertension 7-Allergy or contraindications to letrozole or CC 8-Clinical suspicion of other etiologies that mimics PCOS like androgen secreting tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure is ovulation rate which is Indicated by mid luteal progesterone level more than 3 ng per mLTimepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Size and number of developing follicles on serial USG between D10 to 16 Timepoint: 2 years;Endometrial thickness on cycle day 12 to 16 on ultrasoundTimepoint: 2 years;Adverse events related to the study medications like OHSSTimepoint: 2 years;Conception or pregnancy rate a positive serum or urinary test of hCG Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Manu Goyal
AIIMS JODHPUR
Outcome results
None listed