Costs and effects of a structured lifestyle program in overweight and obese subfertile couples to prevent unnecessary treatment and improve reproductive outcome.;Titel follow-up: -WOMB women - Preconception lifestyle intervention: does it affect long term female health? -WOMB kids - Preconception lifestyle intervention: does it affect offspring*s health?
- Conditions
- subfertility and overweight100147011001027310013356
- Registration Number
- NL-OMON44962
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 870
Subfertile women with a BMI between 29 kg/m² and 40 kg/m². Women have to be between 18 and 38 years old.
Subfertility is defined as failure to conceive within 12 months of unprotected intercourse in couples where the woman has an ovulatory cycle, as well as couples where the women suffers from chronic anovulation due to WHO I or II or PCO. ;For the follow-up study WOMB kids, singletons of women included in the Lifestyle study that are conceived within 24 months follow-up are included.
Couples suffering from azoospermia or donor semen, severe endometriosis AFS 3 and 4 (Revised American Fertilty Society classification), chronic anovulation due to WHO III, endocrinopathies (like: cushing syndrome, adrenal hyperplasia, hypothyroidism, diabetes mellitus type I will not be eligible for the study. Patients with hypertension, pregnancy induced hypertension, preeclampsia, eclampsia or HELLP syndrome in a former pregancy will be excluded from this study. Incapacitated adults will be not asked to participating in the study, minors are excluded as well. ;Multiples of women included in the Lifestyle study that are conceived within 24 months follow-up are excluded for the follow-up study WOMB Kids.
Children with congenital cardiovascular abnormalities and/or hypertension will not be eligible for the WOMB kids stage 3 'hospital visit'.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be: a healthy singleton of more than 37 week<br /><br>gestation born after vaginal delivery. The initial analysis, will be done by<br /><br>intention to treat, so we will not make a difference for treatment independent<br /><br>pregnancies and pregnancies that occurred after treatment.<br /><br><br /><br>Primary endpoint of the follow-up is BMI.</p><br>
- Secondary Outcome Measures
Name Time Method