Combined clomiphene and letrozole for ovulation induction in infertility patients with Polycystic ovarian syndrome.

Not Applicable

Completed

• Conditions: Health Condition 1: N970- Female infertility associated withanovulationHealth Condition 2: E282- Polycystic ovarian syndrome

• Registration Number: CTRI/2020/09/028012
• Lead Sponsor: Dr Soumya Ranjan Panda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-05-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Patients attending the infertility clinic in the Department of Obstetrics and Gynecology at AIIMS, Mangalagiri will be included in our study if the following inclusion criterias are fulfilled.

1)The age of the patient is between 20 yrs to 40 yrs

2)Diagnosed as PCOS according to Rotterdam critetria.

3)a normal hysterosalpingogram or laparoscopy has been documented;

4)no recorded history of pelvic surgery and/or pelvic inflammatory disease;

5)Male partners having a normal semen analysis, according to the 2010 World Health Organization criteria, within the preceding 6 months and

6)no history of treatment with exogenous gonadotropin.

Exclusion Criteria

1)Endocrine factors other than anovulatory PCOS like hyperprolactinemia, hypothalamic amenorrhea, premature ovarian failure and ovarian tumor or clinical suspicion of other etiologies that mimic PCOS warranting additional evaluation.

2)uncorrected thyroid disease; uncontrolled type 1 or 2 diabetes mellitus or hypertension.

3)allergy or contraindications to letrozole or CC.

4)Other associated factors of infertility like male factor, uterine factor and endometriosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be ovulation, defined as a rupture of dominant follicle as on TVS or mid-luteal progesterone level more than 3 ng/mL. This was tested on cycle day 21 <br/ ><br>Timepoint: 2 to 3 weeks after randomisation

Secondary Outcome Measures

Name	Time	Method
pregnancy loss, including biochemical miscarriage or ectopic pregnancyTimepoint: upto 20 weeks of pregnancy;size and number of developing follicles and endometrial thickness noted in TVS on cycle day 12â??14;Timepoint: 10-12 days after randomisation;adverse events related to the medicationsTimepoint: throughout the study duration;clinical pregnancyTimepoint: 6-8 weeks after randomisation;conceptionTimepoint: 4-6 weeks after randomisation;live birthTimepoint: at the time of delivery of the patient;multiple pregnancyTimepoint: 14-16 weeks after randomisation