MYPP-trial: Myo-inositol Supplementation to Prevent Pregnancy Complications in Women with Polycystic Ovary Syndrome: a multicentre double-blind randomised controlled trial

Completed

• Conditions: PCOS; polycystic ovary syndrome; 10014701; 10018515; 10010273

• Registration Number: NL-OMON52766
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 464

Inclusion Criteria

- >= 18 years of age
- Diagnosis of PCOS according to the Rotterdam consensus criteria and confirmed
by a gynaecologist
- A viable singleton pregnancy confirmed by ultrasound
- Being able to initiate the use of study supplements between 8+0 and 16+0
weeks gestational age
- Ability to understand Dutch or English
- Ability to provide written informed consent

Exclusion Criteria

- Diagnosis of pre-existent type-1 or 2 diabetes mellitus
- Pre-existent renal failure, defined as an estimated glomerular filtration
rate (eGFR) less than 50 ml/min/1.73m2
- Use of myo-inositol supplements, other insulin-mimetics, hypoglycaemic agents
(e.g. metformin) and/or systemic steroids, that cannot be discontinued at the
time of inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified