Health Condition 1: N970- Female infertility associated withanovulation
Conditions
Interventions
Intervention1: Myo-inositol: Myo-inositol,4 grams daily, for three months followed by ovulation induction (OI) with letrozole x 5 mg daily for up to three cycles along with myo-inositol for next 3 mon
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Women with PCOS, wishing to conceive and have Body mass index more than or equal to 19 kg/m2 but less than or equal to 35 kg/m2 Duration of infertility less than or equal 6 years. Willing to participate in the study and give written informed consent.
Exclusion criteria
Exclusion criteria: Couple not available for follow-up period (six months) Pregnancy Other androgen excess conditions such as late-onset CAH, androgen secreting tumours. Diabetes mellitus Pre -diabetic already on Metformin or another anti-diabetic Untreated hypothyroidism (TSH more than 10 iu/ml) or hyper prolactinemia (more than 70 ng/ml) On psychiatric medications or having chronic liver or renal disease in which the interventional or control drugs are relatively contraindicated Previous history of receiving more than or equal to 12 ovulation induction cycles with Letrozole or Clomiphene or other ovulation induction treatment cycles with gonadotrophin or a combination of oral ovulogens and gonadotrophins Other conditions of infertility that assisted reproduction such as severe male factor, advanced endometriosis, male partner with azoospermia, and documented severe tubal disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate per woman randomizedTimepoint: Baseline to 16 months post-randomization for participants who conceive within six months post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rateTimepoint: Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization;Ongoing pregnancy rateTimepoint: Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization;Miscarriage rateTimepoint: Time frame: baseline to 12 months post-randomization for participants who conceive within 6 months after randomization;Ectopic pregnancy rateTimepoint: Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization;Stillbirth rateTimepoint: Time frame: baseline to 16 months post-randomization for participants who conceive within six months post-randomization;Time to pregnancyTimepoint: Time frame: baseline to 8 months post-randomization for participants who conceive within 6 months after randomization;Positive pregnancy rateTimepoint: Time frame: baseline to 7 months for participants who conceive within six months after randomization;Differences in anthropometric parametersTimepoint: Time frame: baseline to 6 months after randomization;Improvement in hormonal & metabolic parametersTimepoint: Time frame: baseline to 6 months post randomization;Pregnancy-related complicationsTimepoint: Time frame: baseline to 17 months post-randomization for participants who conceive within 6 months following randomization;Improvement in menstrual regularityTimepoint: Time frame: baseline to 6 months after randomization;Drug-related side effectsTimepoint: Time frame: baseline to 8 months post randomization;Epigenetic changesTimepoint: Baseline & 6 months post intervention | — |
Countries
India
Contacts
Public ContactDr Mohan S Kamath
CMC, Vellore
Outcome results
None listed