Cited by 308Reproductive Health and TechnologiesOvarian function and disordersAssisted Reproductive Technology and Twin Pregnancy

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Randomized Trial of a Lifestyle Program in Obese Infertile Women

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Mutsaerts, Meike A.Q., van Oers, Anne M., Groen, Henk, Burggraaff, Jan M., Kuchenbecker, Walter K.H., Perquin, Denise A.M., Koks, Carolien A.M., van Golde, Ron, Kaaijk, Eugenie M., Schierbeek, Jaap M., Oosterhuis, Gerrit J.E., Broekmans, Frank J., Bemelmans, Wanda J.E., Lambalk, Cornelis B., Verberg, Marieke F.G., van der Veen, Fulco, Klijn, Nicole F., Mercelina, Patricia E.A.M., van Kasteren, Yvonne M., Nap, Annemiek W., Brinkhuis, Egbert A., Vogel, Niels E.A., Mulder, Robert J.A.B., Gondrie, Ed T.C.M., de Bruin, Jan P., Sikkema, J. Marko, de Greef, Mathieu H.G., ter Bogt, Nancy C.W., Land, Jolande A., Mol, Ben W.J., Hoek, Annemieke·2016·New England Journal of Medicine

DOI 10.1056/nejmoa1505297

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Abstract

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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Adamyan, L. V., Avetisyan, J. S., Seregina, V. Y., Pivazyan, L. G., Mailova, K. S., Osipova, A. A., & Stepanian, A. A. (2025) · Russian Journal of Human Reproduction · doi:10.17116/repro2025310516
Lifestyle intervention before and during fertility treatment in women with obesity or with overweight and PCOS—a RCT
Bélan, M., Giguère-Johnson, M., Carranza‐Mamane, B., Pesant, M.-H., Ainmelk, Y., Langlois, M., Lavoie, H. B., Greenblatt, E. M., Laredo, S., Sagle, M. A., et al. (2025) · The Journal of Clinical Endocrinology & Metabolism · doi:10.1210/clinem/dgaf660 · Cited by 1
Additional file 2 of Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
Erőss, B., Molnár, Z., Szakács, Z., Zádori, N., Szakó, L., Váncsa, S., Juhász, M. F., Ocskay, K., Vörhendi, N., Márta, K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13023545
Additional file 1 of Revisiting the predictability of follicular fluid leptin and related adiposity measures for live birth in women scheduled for ICSI cycles: a prospective cohort study
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Additional file 3 of Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
Erőss, B., Molnár, Z., Szakács, Z., Zádori, N., Szakó, L., Váncsa, S., Juhász, M. F., Ocskay, K., Vörhendi, N., Márta, K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13023548
Additional file 1 of Association between pre-gravid body mass index and clinical outcomes in in vitro fertilization: a multicentered retrospective cohort study
Liu, X., Chen, P., Wang, M., Zhao, W., Jin, L., Shi, J., Mao, Y., Zhang, C., Liang, X., & Huang, R. (2024) · Figshare · doi:10.6084/m9.figshare.26231226
Additional file 1 of Diet normalization or caloric restriction as a preconception care strategy to improve metabolic health and oocyte quality in obese outbred mice
Smits, A., Marei, W. F. A., Neubourg, D. D., & Leroy, J. (2021) · Figshare · doi:10.6084/m9.figshare.16935743
Additional file 4 of Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
Erőss, B., Molnár, Z., Szakács, Z., Zádori, N., Szakó, L., Váncsa, S., Juhász, M. F., Ocskay, K., Vörhendi, N., Márta, K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13023551
Additional file 1 of Effect of lifestyle or metformin interventions before IVF/ICSI treatment on infertile women with overweight/obese and insulin resistance: a factorial design randomised controlled pilot trial
Wang, X., 蔡素芬, Tang, S., Yang, L., Tan, J., Sun, X., & Gong, F. (2023) · Figshare · doi:10.6084/m9.figshare.24130253
Additional file 1 of Personalised health education against health damage of COVID-19 epidemic in the elderly Hungarian population (PROACTIVE-19): protocol of an adaptive randomised controlled clinical trial
Erőss, B., Molnár, Z., Szakács, Z., Zádori, N., Szakó, L., Váncsa, S., Juhász, M. F., Ocskay, K., Vörhendi, N., Márta, K., et al. (2020) · Figshare · doi:10.6084/m9.figshare.13023542
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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: Groen, Henk
Koks, Carolien A.M.
Broekmans, Frank J.
Bemelmans, Wanda J.E.
Lambalk, Cornelis B.
Verberg, Marieke F.G.
Klijn, Nicole F.
Nap, Annemiek W.
Land, Jolande A.
Mol, Ben W.J.
Hoek, Annemieke
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
DOI: 10.1056/nejmoa1505297
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
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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Randomized Trial of a Lifestyle Program in Obese Infertile Women

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