BAMBINI: Bariatric surgery vs Medical care for obesity and polycystic ovarian syndrome related infertility

Not Applicable

Completed

• Conditions: Polycystic ovarian syndrome, obesity; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN16668711
• Lead Sponsor: Imperial College London

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38782004/ (added 04/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Study Completion: 2023-04-17
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Current inclusion criteria as of 20/02/2023:
1. Pre-menopausal women 18 years and older
2. BMI more than or equal to 35 kg/m² with obesity-related complications
3. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018

Previous inclusion criteria:
1. Pre-menopausal women 18 years and older
2. BMI more than or equal to 35 kg/m²
3. Obesity-related complications
4. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018
5. Polycystic ovaries on ultrasound

Exclusion Criteria

1. Type 1 or 2 diabetes mellitus
2. Specific contraindications to obesity surgery
3. Previous obesity surgery
4. Inability to maintain adequate contraception
5. Use of medications affecting reproductive function at screening/3 months prior
6. Other causes of anovulation
7. Current pregnancy/breastfeeding
8. Any medical/psychological/other condition which would potentially either interfere with the study or cause harm to the volunteer
9. Without access at home to a telephone or other factor likely to interfere with the ability to participate reliably in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified