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Ovulation Induction for Anovulatory Infertility in female with PCOS

Combination of Letrozole and Clomiphene Citrate Versus Letrozole alone for ovulation induction in women with polycystic ovary syndrome-a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025688
Enrollment
84
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

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: Combination of Letrozole and Clomiphene Citrate Versus Letrozole alone for ovulation induction in women with polycystic ovary syndrome-a Randomized Controlled Trial: Letrozole 2.5 mg +

Sponsors

Dr Anupama Bahadur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Women 20â??35 years of age with PCOS(according to Rotterdam criteria). 2-Primary / Secondary Infertile women with PCOS 3-BMI 4-Willing to participate in study and follow up

Exclusion criteria

Exclusion criteria: 1-Pregnancy 2-Patient already on other drugs for treatment of PCOS like OCPs 3-Other known cause of infertility (Endometriosis, Unexplained Infertility, Moderate to severe male factor infertility) 4-Deranged kidney or liver function tests 5-Uncontrolled Thyroid disorders 6-Untreated hyperprolactinemia 7-Women with any other endocrinological disorders 8-Medical conditions not well controlled or not recommended during pregnancy (i.e., uncontrolled type 1 or 2 diabetes mellitus, hypertension, hypothyroidism) 9-Allergy or contraindications to letrozole or CC 10-Clinical suspicion of other etiologies that mimic PCOS warranting additional evaluation

Design outcomes

Primary

MeasureTime frame
Total number of women attaining clinical pregnancy in either group (confirmed by USG)Timepoint: 18 months

Secondary

MeasureTime frame
1. Ovulation rate 2. Number of OHSS(Ovarian Hyper-Stimulation Syndrome) cases 3. Number of abortions 4. Numberof ectopic or multiple pregnancies Timepoint: 18 months

Countries

India

Contacts

Public ContactDr Anupama Bahadur

All India Institute Of Medical Sciences, Rishikesh

anupama.bahadur@gmail.com9810326959

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026