Randomized trial of a lifestyle program in obese infertile women
Open accessAbstract
BACKGROUND: Small lifestyle-intervention studies suggest that modest weight loss increases the chance of conception and may improve perinatal outcomes, but large randomized, controlled trials are lacking. METHODS: We randomly assigned infertile women with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 29 or higher to a 6-month lifestyle intervention preceding treatment for infertility or to prompt treatment for infertility. The primary outcome was the vaginal birth of a healthy singleton at term within 24 months after randomization. RESULTS: We assigned women who did not conceive naturally to one of two treatment strategies: 290 women were assigned to a 6-month lifestyle-intervention program preceding 18 months of infertility treatment (intervention group) and 287 were assigned to prompt infertility treatment for 24 months (control group). A total of 3 women withdrew consent, so 289 women in the intervention group and 285 women in the control group were included in the analysis. The discontinuation rate in the intervention group was 21.8%. In intention-to-treat analyses, the mean weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group (P<0.001). The primary outcome occurred in 27.1% of the women in the intervention group and 35.2% of those in the control group (rate ratio in the intervention group, 0.77; 95% confidence interval, 0.60 to 0.99). CONCLUSIONS: In obese infertile women, a lifestyle intervention preceding infertility treatment, as compared with prompt infertility treatment, did not result in higher rates of a vaginal birth of a healthy singleton at term within 24 months after randomization. (Funded by the Netherlands Organization for Health Research and Development; Netherlands Trial Register number, NTR1530.).
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Seven studies met the inclusion criteria for this review, only three of which reported on live birth or ongoing pregnancy (Belan 2019, Mutsaerts 2016, Rossi 2013), and one provided data on live birth on request (Oostingh 2020).
“Seven studies met the inclusion criteria for this review, only three of which reported on live birth or ongoing pregnancy (Belan 2019, Mutsaerts 2016, Rossi 2013), and one provided data on live birth on request (Oostingh 2020).”
From Preconception lifestyle advice for people with infertility (2021) · cites this paper as Mutsaerts 2016
The predefined safety outcomes (adverse events and miscarriage) were reported in only one study (Mutsaerts 2016).
“The predefined safety outcomes (adverse events and miscarriage) were reported in only one study (Mutsaerts 2016).”
From Preconception lifestyle advice for people with infertility (2021) · cites this paper as Mutsaerts 2016
In Mutsaerts 2016, at 6 months, sugary drink consumption was lower in the experimental group than control, with a mean difference of -0.41 (95% CI -0.47 to -0.34).
“Mutsaerts 2016 Sugary drinks in glasses/d at 6 months (mean ± SD) 0.59 ± 0.2 glasses/d in experimental group (n = 88) 0.99 ± 0.3 glasses/d in control group (n = 128) MD -0.41, 95% CI -0.47 to -0.34”
From Preconception lifestyle advice for people with infertility (2021) · cites this paper as Mutsaerts 2016
In Mutsaerts 2016, at 6 months, savoury snack consumption was lower in the experimental group than control, with a mean difference of -0.15 (95% CI -0.35 to 0.05).
“Savoury snacks in handfuls/week at 6 months (mean ± SD) 2.17 ± 0.73 handfuls/week in experimental group (n = 100) 2.32 ± 0.81 handfuls/week in control group (n = 139) MD -0.15, 95% CI -0.35 to 0.05”
From Preconception lifestyle advice for people with infertility (2021) · cites this paper as Mutsaerts 2016
In Mutsaerts 2016, at 6 months, sweet snack consumption was lower in the experimental group than control, with a mean difference of -1 (95% CI -1.14 to -0.85).
“Sweet snacks in portions/week at 6 months (mean ± SD) 1.725 ± 0.32 portion/week in experimental group (n = 99) 2.72 ± 0.79 portion/week in control group (n = 136) MD -1, 95% CI -1.14 to -0.85”
From Preconception lifestyle advice for people with infertility (2021) · cites this paper as Mutsaerts 2016
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Self-citationImpact of obesity on male and female reproductive outcomes
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Self-citationOptimizing reproductive health in women with obesity and infertility
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Self-citationC-reactive protein and ART outcomes: a systematic review
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Self-citationObesity: A Doorway to a Molecular Path Leading to Infertility
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Self-citationPreconception Lifestyle and Cardiovascular Health in the Offspring of Overweight and Obese Women
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Self-citationMr. Fertility Authority, Tear Down That Weight Wall!
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- Authors
- Mutsaerts, M. A. Q., van Oers, A. M., Groen, H., Burggraaff, J. M., Kuchenbecker, W. K. H., Perquin, D. A. M., Koks, C. A. M., van Golde, R., Kaaijk, E. M., Schierbeek, J. M., Oosterhuis, G. J. E., Broekmans, F. J., Bemelmans, W. J. E., Lambalk, C. B., Verberg, M. F. G., van der Veen, F., Klijn, N. F., Mercelina, P. E. A. M., van Kasteren, Y. M., Nap, A. W., Brinkhuis, E. A., Vogel, N. E. A., Mulder, R. J. A. B., Gondrie, E. T. C. M., de Bruin, J. P., Sikkema, J. M., de Greef, M. H. G., ter Bogt, N. C. W., Land, J. A., Mol, B. W. J., & Hoek, A.
- Affiliations
- University Medical Center Groningen (NL)
- From the Departments of Obstetrics and Gynecology (M.A.Q.M., A.M.O., J.A.L., A.H.), General Practice (M.A.Q.M.), and Epidemiology (H.G.), and the Institute of Human Movement Sciences (M.H.G.G.), University Medical Center Groningen, University of Groningen, the Department of Obstetrics and Gynecology, Martini Hospital (N.E.A.V.), and the Research and Innovation Group in Health Care and Nursing, Hanze University of Applied Sciences (M.H.G.G.), Groningen, the Department of Obstetrics and Gynecology, Scheper...
- Leiden University (NL)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2016-05-19
- Volume
- 374
- Issue
- 20
- Pages
- 1942-1953
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2404662288
- Cited by
- 308
- References
- 39
- Citations by year
- 2026: 21 · 2025: 25 · 2024: 28 · 2023: 25 · 2022: 34 · 2021: 35 · 2020: 34 · 2019: 27 · 2018: 38 · 2017: 29 · 2016: 10 · 2015: 1 · 2014: 1
- FWCI
- 45.90
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (publishedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion, other-oa)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Leiden Repository (Leiden University) (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Utrecht University Repository (Utrecht University) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Rivm Repository (Netherlands National Institute for Public Health and the Environment) (submittedVersion)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Utrecht University Repository (Utrecht University) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Reproductive Medicine › Reproductive Health and Technologies
- Health Sciences › Medicine › Reproductive Medicine › Ovarian function and disorders
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Assisted Reproductive Technology and Twin Pregnancy
- Keywords
- obesity, female infertility, lifestyle intervention, weight loss, infertility treatment, vaginal delivery, singleton births, perinatal outcomes, body mass index
- MeSH terms
- Adult, Birth Rate, Diet, Reducing, Female, Humans, Infertility, Female, Life Style, Obesity, Pregnancy, Weight Loss, Exercise, Body Mass Index, Reproductive Techniques, Assisted, Young Adult, Intention to Treat Analysis
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