Long-term effects of bariatric surgery in women with Polycystic Ovary Syndrome (PCOS), obesity and irregular or absent menstrual periods

Bariatric surgery vs. Medical care for obesity and polycystic ovarian syndrome related infertility: Long-term follow-up of the BAMBINI randomised-controlled clinical trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16272246

Enrollment

Registered

2025-10-20

Start date

2025-09-01

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term effects of bariatric surgery in women with Polycystic Ovary Syndrome, obesity and oligomenorrhoea or amenorrhoea. Nutritional, Metabolic, Endocrine

Interventions

This study will invite all participants who took part in the BAMBINI clinical trial (ISRCTN16668711) and received their randomly allocated intervention to attend for a single visit. At this visit, the

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Participants from the BAMBINI clinical trial who received their randomly allocated trial intervention. As part of the initial trial, participants gave their consent to be contacted for potential participation in other research studies.

Exclusion criteria

Exclusion criteria: Patients who did not receive their randomly allocated intervention as part of the original BAMBINI clinical trial.

Design outcomes

Primary

Measure	Time frame
Number of patient-reported menstrual cycles in the last 12 months	—

Secondary

Measure	Time frame
Metabolic outcomes: 1. Body weight is measured using calibrated digital scales at baseline and 1 year 2. Body mass index (BMI) is calculated from measured height and weight at baseline and 1 year 3. Waist circumference is measured using a non-stretchable tape at baseline and 1 year 4. Body composition is measured using dual-energy X-ray absorptiometry (DEXA) at baseline and 1 year 5. Plasma lipid concentration is measured using enzymatic colorimetric assays from a fasting blood sample at baseline and 1 year 6. Plasma liver function tests (ALT, AST, ALP, GGT, bilirubin) are measured using automated clinical chemistry analyzers from a fasting blood sample at baseline and 1 year 7. Plasma HbA1c is measured using high-performance liquid chromatography (HPLC) from a fasting blood sample at baseline and 1 year 8. Plasma fasting glucose is measured using a glucose oxidase method from a fasting blood sample at baseline and 1 year 9. Serum fasting insulin is measured using immunoassay from a fasting blood sample at baseline and 1 year 10. Fasting plasma C-peptide is measured using immunoassay from a fasting blood sample at baseline and 1 year 11. Arterial blood pressure is measured using an automated sphygmomanometer following standard protocols at baseline and 1 year 12. High sensitivity CRP is measured using immunoturbidimetric assay from a fasting blood sample at baseline and 1 year 13. Serum steroid metabolomics is measured using liquid chromatography–mass spectrometry (LC-MS) from a fasting blood sample at baseline and 1 year Reproductive and hormonal outcomes: 14. Pregnancy, miscarriage, and live birth rates are recorded using a structured reproductive history questionnaire at baseline and 1 year 15. Neonatal outcomes are recorded using a structured birth outcome questionnaire at delivery 16. Use of Assisted Reproductive Technology (ART) is recorded using a structured fertility treatment questionnaire at baseline and 1 year 17. Serum LH	—

Measure

Time frame

Metabolic outcomes: 1. Body weight is measured using calibrated digital scales at baseline and 1 year 2. Body mass index (BMI) is calculated from measured height and weight at baseline and 1 year 3. Waist circumference is measured using a non-stretchable tape at baseline and 1 year 4. Body composition is measured using dual-energy X-ray absorptiometry (DEXA) at baseline and 1 year 5. Plasma lipid concentration is measured using enzymatic colorimetric assays from a fasting blood sample at baseline and 1 year 6. Plasma liver function tests (ALT, AST, ALP, GGT, bilirubin) are measured using automated clinical chemistry analyzers from a fasting blood sample at baseline and 1 year 7. Plasma HbA1c is measured using high-performance liquid chromatography (HPLC) from a fasting blood sample at baseline and 1 year 8. Plasma fasting glucose is measured using a glucose oxidase method from a fasting blood sample at baseline and 1 year 9. Serum fasting insulin is measured using immunoassay from a fasting blood sample at baseline and 1 year 10. Fasting plasma C-peptide is measured using immunoassay from a fasting blood sample at baseline and 1 year 11. Arterial blood pressure is measured using an automated sphygmomanometer following standard protocols at baseline and 1 year 12. High sensitivity CRP is measured using immunoturbidimetric assay from a fasting blood sample at baseline and 1 year 13. Serum steroid metabolomics is measured using liquid chromatography–mass spectrometry (LC-MS) from a fasting blood sample at baseline and 1 year Reproductive and hormonal outcomes: 14. Pregnancy, miscarriage, and live birth rates are recorded using a structured reproductive history questionnaire at baseline and 1 year 15. Neonatal outcomes are recorded using a structured birth outcome questionnaire at delivery 16. Use of Assisted Reproductive Technology (ART) is recorded using a structured fertility treatment questionnaire at baseline and 1 year 17. Serum LH

—

Countries

England, United Kingdom

Contacts

Public ContactSuhaniya Samarasinghe

suhaniya.samarasinghe@nhs.net+44 207 594 5444

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026