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Lifestyle

Costs and effects of a structured lifestyle program in overweight and obese subfertile couples to prevent unnecessary treatment and improve reproductive outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27911
Enrollment
570
Registered
2008-11-16
Start date
2009-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Subfertility affects approximately one in ten couples planning conception. Among subfertile women, about 30% are overweight or even obese. Epidemiological data suggest that the reduction of overweight will increase the chances of conception, decrease pregnancy complications and improve perinatal outcome. In small intervention studies beneficial reproductive effects of improvement of lifestyle leading to a reduction in body weight have been demonstrated. The British Fertility Society advises that

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 of
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 care”

Sponsors

ZonMW Laan van Nieuw Oost Indië 334 2593 CE Den Haag T: 07-3495111
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subfertile women (age 18-38) with a BMI between 29 and 40

Exclusion criteria

Exclusion criteria: 1. Are azoospermia 2. Severe endometriosis 3. Chronic anovulation due to WHO III 4. Endocrinopathies.

Design outcomes

Primary

MeasureTime frame
- Primary endpoint is the birth of a healthy singleton after vaginal delivery of at least 37 weeks gestation.

Secondary

MeasureTime frame
- Secondary outcome parameters are: - number of fertility treatments (OI, IUI, IVF, ICSI) - clinical and ongoing pregnancy rates - perinatal outcome - complications - quality of life - body weight - waist circumference - behaviour influencing weight, i.e. - nutritional habits - exercise pattern - smoking habits - blood pressure - glucose/insulin ratio (HOMA) - costs.

Contacts

Public ContactA. Hoek

University Medical Center Groningen (UMCG) Section of Reproductive Medicine Dept. Obstetrics and Gynaecology

a.hoek@og.umcg.nl+31 (0)50 3613152

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)