CompletedObservational

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

This study is a follow-up to an earlier trial and looks at the long-term health of women who previously had weight-loss surgery for Polycystic Ovary Syndrome (PCOS) and obesity. PCOS can cause irregular periods and make getting pregnant harder, especially with obesity. The original study, called BAMBINI, found that weight-loss surgery helped women with PCOS have more regular periods. This new study will gather information over time to see the lasting effects of that surgery on their ability to have children, their general health, and how well they feel in their daily lives. We hope this will give us a clearer picture of the long-term benefits.

At a glance

Status

Completed

Sponsor

NIHR Imperial Biomedical Research Centre

Enrolment target

Start

01 Sep 2025

Estimated completion

02 May 2026

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

What is this study about?

You might be invited to join a research study that looks at the long-term effects of weight-loss surgery, also known as bariatric surgery, for women with a condition called Polycystic Ovary Syndrome (PCOS) and obesity. PCOS can cause problems like irregular or missed periods and can make it harder to get pregnant. Being overweight can make these symptoms even worse. An earlier study, called BAMBINI, found that weight-loss surgery could help women with PCOS and obesity have more regular periods, which is important for fertility.

This new study is a follow-up to the BAMBINI trial. It wants to understand what happens to women in the years after their surgery. Researchers will collect information to see how the surgery has affected their ability to have children, their overall health (like how their body uses energy), and their general well-being and quality of life over a long period. This is important because it helps us learn more about the lasting benefits of such surgery.

By taking part, you would be helping doctors and researchers understand more about how weight-loss surgery impacts women with PCOS for many years. This knowledge can then be used to help future patients make informed decisions about their treatment, potentially improving health outcomes for many women.

Key takeaways

This study follows up on women who previously had weight-loss surgery for PCOS and obesity.
It aims to understand the long-term effects on fertility, general health, and well-being.
Participation involves attending visits to share information about your health.
There are no new treatments or procedures involved, so no significant new risks.
The study helps doctors understand the lasting benefits of weight-loss surgery for women with PCOS.
It's running from April 2025 to September 2026 in London.

Who may be eligible?

This study is specifically for women who previously took part in the original BAMBINI trial. You needed to have received your assigned treatment (either weight-loss surgery or standard medical care) as part of that first study.

If you were in the BAMBINI trial but didn't receive the treatment you were assigned, then this follow-up study wouldn't be suitable for you.

Basically, if you completed the first BAMBINI study, you might be invited to take part in this important follow-up research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Were you a participant in the original BAMBINI clinical trial?
Did you receive the specific treatment (either surgery or standard care) you were assigned in the BAMBINI trial?
Are you female?

Answer every question to see your result.

What does participation involve?

This study is an 'observational' study, which means you won't be given any new treatments or medicines. Instead, researchers will simply gather information from you. If you're invited and agree to take part, you'll be asked to attend some follow-up visits. During these visits, the research team will ask questions and collect information about your health, your fertility journey, and how you're feeling generally. There are no new procedures involved. The study is planned to run from April 2025 to September 2026, so your involvement would be within that timeframe.

Potential risks and benefits

Taking part in this study won't involve any new medical treatments or procedures, so there are no significant risks to your health. The main benefit for you is knowing that you are helping researchers understand the long-term effects of weight-loss surgery, especially for women with PCOS. This valuable information will help improve care for future patients. Remember, you can decide to stop participating at any time without giving a reason, and it won't affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NIHR Imperial Clinical Research Facility
City only
London, England

Common questions

What is PCOS?

PCOS stands for Polycystic Ovary Syndrome. It's a common condition that can affect a woman's hormone levels, periods, and ability to get pregnant.

What is bariatric surgery?

Bariatric surgery is a type of weight-loss surgery that helps people lose a lot of weight by making changes to their digestive system.

What does 'observational study' mean?

An observational study means doctors are just watching and collecting information about your health over time. They won't give you any new treatments or ask you to do anything different.

Will I get any medicine or treatment in this study?

No, this study is about observing, not giving new treatments. You won't receive any new medicines or have any procedures done as part of this research.

Where is the study happening?

The study is based at the NIHR Imperial Clinical Research Facility at Hammersmith Hospital in London, UK.

How to find out more

Suhaniya Samarasinghe

suhaniya.samarasinghe@nhs.net +44 207 594 5444 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.