Effectiveness of Myo-inositol versus Metformin in women with PCOS who wish to conceive: A multicentre, randomized controlled trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 1,305
- Locations
- 6
- Primary Endpoint
- Live birth rate per woman randomized
Study Overview
Brief Summary
The polycystic ovarian syndrome (PCOS) is a common gynaecological condition that affects women in the reproductive age group. Currently, between 15-20 million couples are affected in India, and PCOS is a common cause of infertility. Apart from infertility, PCOS is associated with long term complications such as cardiovascular diseases, diabetes mellitus as well as endometrial cancer. Commonly, apart from lifestyle intervention, Metformin therapy along with ovulation induction with Letrozole is considered as first-line pharmacological intervention. However, in contemporary practice, Myo inositol has also been used as an alternative to Metformin although the supportive evidence for Myo inositol is weak. Furthermore, there is scare data from the South Asian region. The current trial has been planned to study the effectiveness of Myo inositol in women with PCOS who wish to conceive and compare it against the Metformin as well as placebo.
The main objective of the study is to assess whether fertility-related outcomes improve following Myoinositol compared to Metformin and placebo in women with PCOS who wish to concieve. The secondary objectives include assessing whether there is improvement in endocrinological & metabolic parameters as well as obstetrics outcomes following Myoinositol versus Metformin & placebo. Finally, we also want to asses if there are any epigenetic changes pre and post-intervention.
The study is a multicentre placebo controlled randomized study involving women with PCOS who wish to conceive. The study results will inform us on whether use of Myoinositol is beneficial for women with PCOS who wish to conceive and fill in the knowledge gap in the area. It
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 19.00 Year(s) to 37.00 Year(s) (—)
- Sex
- Female
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
- •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.
Outcomes
Primary Outcomes
Live birth rate per woman randomized
Time Frame: Baseline to 16 months post-randomization for participants who conceive within six months post-randomization
Secondary Outcomes
- Clinical pregnancy rate(Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization)
- Ongoing pregnancy rate(Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization)
- Miscarriage rate(Time frame: baseline to 12 months post-randomization for participants who conceive within 6 months after randomization)
- Ectopic pregnancy rate(Time frame: baseline to 9 months post-randomization for participants who conceive within 6 months after randomization)
- Stillbirth rate(Time frame: baseline to 16 months post-randomization for participants who conceive within six months post-randomization)
- Time to pregnancy(Time frame: baseline to 8 months post-randomization for participants who conceive within 6 months after randomization)
- Positive pregnancy rate(Time frame: baseline to 7 months for participants who conceive within six months after randomization)
- Differences in anthropometric parameters(Time frame: baseline to 6 months after randomization)
- Improvement in hormonal & metabolic parameters(Time frame: baseline to 6 months post randomization)
- Pregnancy-related complications(Time frame: baseline to 17 months post-randomization for participants who conceive within 6 months following randomization)
- Improvement in menstrual regularity(Time frame: baseline to 6 months after randomization)
- Drug-related side effects(Time frame: baseline to 8 months post randomization)
- Epigenetic changes(Baseline & 6 months post intervention)
Investigators
Dr Mohan S Kamath
CMC, Vellore