A randomized controlled multicenter trial comparing bariatric surgery with a structured life style intervention program in subfertile obese women with PCOS

A randomized controlled multicenter trial comparing bariatric surgery with a structured life style intervention program in subfertile obese women with PCOS - Bariatric Subfertility Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55712

Enrollment

300

Registered

2015-06-09

Start date

2019-04-26

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Subfertility

Interventions

Bariatric surgery: Laparoscopic Roux-en-Y Gastric Bypass. Operative procedures will be performed by, or under direct supervision of a bariatric surgeon with an experience of at least 200 bariatric o

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: • Age 18-40 years • BMI of 35 kg/m2 or more. • Subfertile women with PCOS • No previous fertility treatment. • Informed consent and willing to enter the follow up program.

Exclusion criteria

Exclusion criteria: • Azoospermia, severe endometriosis, WHO class III anovulation (premature ovarian failure). • Prior fertility treatment. • Prior bariatric surgery. • Prior major abdominal surgery • ASA classification >= IV • Severe concomitant disease. • The inability to understand written information..

Design outcomes

Primary

Measure	Time frame
The number of healthy children, born after at least 37 weeks of gestation during the 3 years follow-up period.	—

Secondary

Measure	Time frame
* percentage effective weight loss. * comorbity related to bariatric surgery. * metabolic and endocrinological changes. * maternal, perinatal and neonatal complications. * comorbiditty related to morbid obesity. * quality of life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)