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A clinical trail to study the effect of inositols in achieving successful pregnancy among women with anovulation, if combined along with letrozole

Phase 3
Conditions
Health Condition 1: E282- Polycystic ovarian syndrome
Registration Number
CTRI/2023/03/050569
Lead Sponsor
Priyanka Yoga P
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1The age of the patient is between 20 yrs to 35 yrs

2Diagnosed as PCOS according to the Rotterdam criteria. (oligomenorrhoea hyperandrogenism (hirsutism, acne, or alopecia) or hyperandrogenemia (elevated levels of total or free T) and typical features of ovaries on ultrasound scan

3A normal hysterosalpingogram or laparoscopy has been documented

4Without any history of pelvic inflammatory disease or pelvic surgery

5Normal uterine cavity

6Male partners having semen analysis parameters within normal range, performed in preceding 6 months

7Without any treatment history of exogenous gonadotropin or metformin.

Exclusion Criteria

1Endocrine factors like hyperprolactinemia, premature ovarian failure, hypothalamic amenorrhea or uncorrected thyroid disease.

2Known cases of uncontrolled type 1 or 2 diabetes mellitus and/or hypertension.

3Allergic reactions or presence of other contraindications for the use of letrozole or CC.

4Other associated factors of infertility like a male factor, uterine factor or endometriosis.

5Myo-inositol use < 3 months prior to study enrolment

6Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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