What is PCOS?

Polycystic ovarian syndrome (PCOS) is a common hormonal disorder that affects women of reproductive age. It causes infrequent or prolonged menstrual periods or excess male hormone (androgen) levels. The ovaries may develop numerous small collections of fluid (follicles) and fail to regularly release eggs.

Oftentimes the signs and symptoms of PCOS show firstly at puberty around the time of the first menstrual period. Sometimes it develops later, e.g. in response to substantial weight gain.

PCOS Symptoms

• Irregular periods (Infrequent, irregular or prolonged menstrual cycles are the most common sign)
  
• Excess androgen (Elevated levels of male hormone resulting in physical signs as excess facial and body hair, and severe acne and male-pattern baldness.)
  
• Polycystic ovaries (Ovaries are enlarged and contain follicles that surround the eggs; resulting in the ovaries failing to function regularly.)
  

Obesity can worsen complications of the disorder and is an associated symptom of PCOS.

Purpose of the study

The Fractyl Revita System ™ has achieved CE-marking and a number of studies support its safety and effectiveness in improving insulin sensitivity (reductions in blood glucose) for patients with Type 2 Diabetes.

Up to 70% of women with PCOS have poor insulin sensitivity making them more likely to develop glucose intolerance and Type 2 diabetes.

The DOMINO trial will investigate both whether this non-invasive device indeed increases insulin sensitivity using gold-standard methodologies but also whether it can help women of reproductive age start menstruating.

The procedure is performed with a camera test and does not involve any form of surgery. It does not require participants to take any form of medication to lower their sugar and no device is left in the patient (click here for further information).

If successful, the DOMINO trial can have a substantial impact on millions of women around the world. The technology could be used as a one-off treatment to enable women with PCOS to get pregnant without exposing them to the side effects of long-term medications or the complications of invasive pelvic interventions.

Publication about the study

https://www.express.co.uk/life-style/health/964287/infertility-pcos-diabetes-women-pregnant-baby-research

Who can participate in this study?

• You may qualify for this research study, if the following applies to you:
  
• You are a woman aged between 18-45 years
  
• Have PCOS (Polycystic ovarian syndrome) symptoms like:  Irregular periods, Excess androgen, Polycystic Ovaries   

OR

• Have been diagnosed with PCOS (Polycystic ovarian syndrome) by a medical professional 

If you are affected by Type 1 - or type 2 Diabetes Mellitus, unfortunately, this study is not suitable for you.

DOMINO study is being conducted at Imperial College London. Patients can choose to have some study visits at University Hospitals Coventry and Warwickshire NHS Trust.

There are other eligibility requirements. A final decision on whether this research study may be suitable for you will be made after you speak with the study doctor at the research site. The study doctor will explain the benefits and risks of participation in this research study.