Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Myo-inositol-2,000mg plus d-chiro-inositol 50mg supplement tablet
Tab Letrozole 2.5mg
: Myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement tablet twice daily for 12weeks
T
Sponsors
Priyanka Yoga P
Eligibility
Inclusion criteria
Inclusion criteria: 1 The age of the patient is between 20 yrs to 35 yrs 2 Diagnosed 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 3 A normal hysterosalpingogram or laparoscopy has been documented 4 Without any history of pelvic inflammatory disease or pelvic surgery 5 Normal uterine cavity 6 Male partners having semen analysis parameters within normal range, performed in preceding 6 months 7 Without any treatment history of exogenous gonadotropin or metformin.
Exclusion criteria
Exclusion criteria: 1 Endocrine factors like hyperprolactinemia, premature ovarian failure, hypothalamic amenorrhea or uncorrected thyroid disease. 2 Known cases of uncontrolled type 1 or 2 diabetes mellitus and/or hypertension. 3 Allergic reactions or presence of other contraindications for the use of letrozole or CC. 4 Other associated factors of infertility like a male factor, uterine factor or endometriosis. 5 Myo-inositol use 6 Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Documentation of ovulation will be the primary outcome of our study which will be determined by rupture of the dominant follicle as documented by performing transvaginal sonographyTimepoint: 12 WEEKS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Size and quantity of developing follicles and endometrial thickness as measured by TVS 2 Conception with the treatment cycle as documented by positive urine or serum hCG test; 3 Clinical pregnancy detected as an intrauterine pregnancy with fetal cardiac activity by ultrasonography 4 Side effect profiles of the drugs including serious adverse events (SAEs) Timepoint: 1. At the end of 12 weeks 2. at the end of 14weeks 3.At the end of 16weeks 4. At the end of 1 week | — |
Countries
India
Contacts
Public ContactSharmila V
AIIMS, Mangalagiri
Outcome results
None listed