subfertility and overweight
Conditions
Interventions
The intervention consists of a structured lifestyle program of six months,
which aims a realistic weight loss of at least 5% to10%, achieved by the
combination of a healthy diet (caloric reduction o
the Groninger Overweight And Lifestyle study (GOAL)).
Following six months of lifestyle intervention patients will start fertility
treatment as indicated in the *usual care* group.
In the *usual car
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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'.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be: a healthy singleton of more than 37 week gestation born after vaginal delivery. The initial analysis, will be done by intention to treat, so we will not make a difference for treatment independent pregnancies and pregnancies that occurred after treatment. Primary endpoint of the follow-up is BMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters are: 1. pregnancy outcome and -complications: miscarriage, gestational diabetes, Pregnancy induced hypertension, preeclampsia, HELLP, prematurity 4200 grams, induction of labour, prolonged duration of labour, operative delivery, and increased blood loss, and multiple pregnancies 2. percentage of women needing fertility treatment in both groups (OI, IUI, IVF, ICSI) and ongoing pregnancy rates in these treatments. 3. Quality and number of oocytes and embryos and cryo embryos resulting from an IVF or ICSI procedure. 4. perinatal outcome: stillbirth, pregnancy duration, body weight and health of neonate, neonatal admission. 5. quality of life, pre-pregnancy body weight, weight gain during pregnancy, waist circumference, behaviour influencing weight, i.e. nutritional habits and exercise pattern, blood pressure, glucose/insulin ratio (HOMA), hormonal and cytokine profile and costs. ECONOMIC EVALUATION: The aim of the economic evaluation is to compare the costs and health effects of a lifestyle program versus *usual care*. The analysis will be a cost-effectiveness analysis with the proportion of healthy singleton of more than 37 week gestation born after vaginal delivery as the primary outcome. Secondary endpoints of the follow-up women is (WOMB women): Anthropometrics and body composition Cardio metabolic health General health Reproductive health Mental health Physical activity Diet and dietary habits Secondary endpoints of the follow-up children is (WOMB kids): Anthropometrics and body composition at 3-5 years. Cardio metabolic health at 3-5 years. Child*s health between 0 and 3-5 years. Child*s growth pattern between 0 and 3-5 years. Child*s development and behavior at 3-5 years. Child*s lifestyle (diet and sleep pattern) at 3-5 years. Child's cardiovascular structure and function at 7-8 years. | — |
Countries
Netherlands
Outcome results
None listed