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

Recruiting

• Conditions: Subfertility; 10018424; 10010273; 10013356

• Registration Number: NL-OMON55712
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 300

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

• 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..

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of healthy children, born after at least 37 weeks of gestation<br /><br>during the 3 years follow-up period. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* percentage effective weight loss.<br /><br>* comorbity related to bariatric surgery.<br /><br>* metabolic and endocrinological changes.<br /><br>* maternal, perinatal and neonatal complications.<br /><br>* comorbiditty related to morbid obesity.<br /><br>* quality of life.</p><br>