Meike A Q Mutsaerts1, Anne M van Oers1, Henk Groen1, Jan M Burggraaff1, Walter K H Kuchenbecker1, Denise A M Perquin1, Carolien A M Koks1, Ron van Golde1, Eugenie M Kaaijk1, Jaap M Schierbeek1, Gerrit J E Oosterhuis1, Frank J Broekmans1, Wanda J E Bemelmans1, Cornelis B Lambalk1, Marieke F G Verberg1, Fulco van der Veen1, Nicole F Klijn1, Patricia E A M Mercelina1, Yvonne M van Kasteren1, Annemiek W Nap1, Egbert A Brinkhuis1, Niels E A Vogel1, Robert J A B Mulder1, Ed T C M Gondrie1, Jan P de Bruin1, J Marko Sikkema1, Mathieu H G de Greef1, Nancy C W ter Bogt1, Jolande A Land1, Ben W J Mol1, Annemieke Hoek1. 1. 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 Hospital, Emmen (J.M.B.), the Department of Obstetrics and Gynecology, Isala Clinics, Zwolle (W.K.H.K.), the Department of Obstetrics and Gynecology, Medical Center Leeuwarden, Leeuwarden (D.A.M.P.), the Department of Obstetrics and Gynecology, Maxima Medical Center, Veldhoven (C.A.M.K.), the Department of Obstetrics and Gynecology, Maastricht University Medical Center, Maastricht University, Maastricht (R.G.), the Department of Obstetrics and Gynecology, Onze Lieve Vrouwe Gasthuis (E.M.K.), the Department of Obstetrics and Gynecology, VU University Medical Center (C.B.L.), and the Center for Reproductive Medicine, Academic Medical Center, University of Amsterdam (F.V.), Amsterdam, the Department of Obstetrics and Gynecology, Deventer Hospital, Deventer (J.M. Schierbeek), the Department of Obstetrics and Gynecology, St. Antonius Hospital, Nieuwegein (G.J.E.O.), the Department of Reproductive Medicine, Division Female and Baby, University Medical Center Utrecht, Utrecht University, Utrecht (F.J.B.), the Center for Prevention and Health Services Research, National Institute for Public Health and the Environment, Bilthoven (W.J.E.B.), the Department of Obstetrics and Gynecology, Medical Spectrum Twente, Enschede (M.F.G.V.), the Department of Gynecology and Reproductive Medicine, Leiden University Medical Center, University of Leiden, Leiden (N.F.K.), the Department of Obstetrics and Gynecology, Atrium Medical Center, Heerlen (P.E.A.M.M.), the Department of Obstetrics a
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-monthlifestyle 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.).
RCT Entities:
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 infertilewomen, 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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