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Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial.
Hum Reprod Open. 2019; 2019(4):hoz030.HR

Abstract

STUDY QUESTION

Did weight reduction in obese women scheduled for IVF increase cumulative live birth rate (CLBR) after 2 years?

SUMMARY ANSWER

Weight loss prior to IVF did not increase CLBR.

WHAT IS KNOWN ALREADY

Few studies have investigated the effect of weight reduction in obese infertile women scheduled for IVF. In a recent randomized controlled trial (RCT), including one IVF cycle, we found no increase in live birth rate after weight reduction. Weight regain after obesity reduction treatment often occurs, and children born to obese women have a higher risk of childhood obesity.

STUDY DESIGN SIZE DURATION

A 2-year follow-up of a multicenter, RCT running between 2012 and 2018 was performed. Out of 317 women randomized to weight reduction followed by IVF treatment or IVF treatment-only, 305 remained in the full analysis set. Of these women, 90.5% (276/305) participated in this study.

PARTICIPANTS/MATERIALS SETTING METHODS

Nine infertility clinics in Sweden, Denmark and Iceland participated in the RCT. Obese women under 38 years of age having a BMI ≥30 and < 35 kg/m2 were randomized to weight reduction and IVF or IVF-only. In all, 160 patients were randomized to a low calorie diet for 12 weeks and 3-5 weeks of weight stabilization, before IVF and 157 patients to IVF-only. Two years after randomization, the patients filled in a questionnaire regarding current weight, live births and ongoing pregnancies.

MAIN RESULTS AND THE ROLE OF CHANCE

42 additional live births were achieved during the follow-up in the weight reduction and IVF group, and 40 additional live births in the IVF-only group, giving a CLBR, the main outcome of this study, of 57.2% (87/152) and 53.6% (82/153), respectively (P = 0.56; odds ratio (OR) 1.16, 95% CI: 0.74-1.52). Most of the women in the weight reduction and IVF group had regained their pre-study weight after 2 years. The mean weight gain over the 2 years was 8.6 kg, while women in the IVF-only group had a mean weight loss of 1.2 kg. At the 2-year follow-up, the weight standard deviation scores of the children born in the original RCT (index cycle) were 0.218 (1.329) (mean, SD) in the weight reduction and IVF group and - 0.055 (1.271) (mean, SD) in the IVF-only group (P = 0.25; mean difference between groups, 0.327; 95% CI: -0.272 to 0.932).

LIMITATIONS REASON FOR CAUTION

All data presented in this follow-up study were self-reported by the participants, which could affect the results. A further limitation is in power for the main outcome. The study is a secondary analysis of a large RCT, where the original power calculation was based on live-birth rate after one cycle and not on CLBR.

WIDER IMPLICATIONS OF THE FINDINGS

The follow-up indicates that for women with a BMI ≥30 and < 35 kg/m2 and scheduled for IVF, the weight reduction did not increase their chance of a live birth either in the index cycle or after 2 years. It also shows that even in this highly motivated group, a regain of pre-study weight occurred.

STUDY FUNDING/COMPETING INTERESTS

The 2-year follow-up was financed by grants from the Swedish state under the agreement between the Swedish Government and the county councils, the ALF-agreement (ALFGBG-70940 and ALFGBG-77690), Merck AB, Solna, Sweden (an affiliate of Merck KGaA, Darmstadt, Germany), Hjalmar Svensson Foundation. Ms Kluge has nothing to disclose. Dr Bergh has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Einarsson has been reimbursed for lectures for Merck and Ferring. Dr Thurin-Kjellberg reports grants from Merck, and reimbursement for lectures from Merck outside the submitted work. Dr Pinborg has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Englund has nothing to disclose.

TRIAL REGISTRATION NUMBER

ClinicalTrials.gov number, NCT01566929.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, 416 84 Gothenburg, Sweden. Reproductive Medicine, Sahlgrenska University Hospital, Blå stråket 6, SE-41345 Gothenburg, Sweden.Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, 416 84 Gothenburg, Sweden. Reproductive Medicine, Sahlgrenska University Hospital, Blå stråket 6, SE-41345 Gothenburg, Sweden.Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, 416 84 Gothenburg, Sweden. Livio Reykjavik, Álfheimar 74, 104 Reykjavik, Iceland.Fertility Clinic, Rigshospital, Copenhagen University Hospital, Juliane Maries Vej 8, 2100 København Ø, Denmark. Zealand Fertility Clinic, Zealand University Hospital, Lykkebækvej 14, 4600 Køege, Denmark.Zealand Fertility Clinic, Zealand University Hospital, Lykkebækvej 14, 4600 Køege, Denmark.Department of Obstetrics and Gynecology, Institute of Clinical Sciences, Sahlgrenska Academy, Gothenburg University, 416 84 Gothenburg, Sweden. Reproductive Medicine, Sahlgrenska University Hospital, Blå stråket 6, SE-41345 Gothenburg, Sweden.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31844684

Citation

Kluge, L, et al. "Cumulative Live Birth Rates After Weight Reduction in Obese Women Scheduled for IVF: Follow-up of a Randomized Controlled Trial." Human Reproduction Open, vol. 2019, no. 4, 2019, pp. hoz030.
Kluge L, Bergh C, Einarsson S, et al. Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Hum Reprod Open. 2019;2019(4):hoz030.
Kluge, L., Bergh, C., Einarsson, S., Pinborg, A., Mikkelsen Englund, A. L., & Thurin-Kjellberg, A. (2019). Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. Human Reproduction Open, 2019(4), hoz030. https://doi.org/10.1093/hropen/hoz030
Kluge L, et al. Cumulative Live Birth Rates After Weight Reduction in Obese Women Scheduled for IVF: Follow-up of a Randomized Controlled Trial. Hum Reprod Open. 2019;2019(4):hoz030. PubMed PMID: 31844684.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cumulative live birth rates after weight reduction in obese women scheduled for IVF: follow-up of a randomized controlled trial. AU - Kluge,L, AU - Bergh,C, AU - Einarsson,S, AU - Pinborg,A, AU - Mikkelsen Englund,A-L, AU - Thurin-Kjellberg,A, Y1 - 2019/12/10/ PY - 2019/07/08/received PY - 2019/09/01/revised PY - 2019/09/12/accepted PY - 2019/12/18/entrez PY - 2019/12/18/pubmed PY - 2019/12/18/medline KW - IVF KW - cumulative live birth rate KW - follow-up KW - infertility KW - obesity KW - weight loss SP - hoz030 EP - hoz030 JF - Human reproduction open JO - Hum Reprod Open VL - 2019 IS - 4 N2 - STUDY QUESTION: Did weight reduction in obese women scheduled for IVF increase cumulative live birth rate (CLBR) after 2 years? SUMMARY ANSWER: Weight loss prior to IVF did not increase CLBR. WHAT IS KNOWN ALREADY: Few studies have investigated the effect of weight reduction in obese infertile women scheduled for IVF. In a recent randomized controlled trial (RCT), including one IVF cycle, we found no increase in live birth rate after weight reduction. Weight regain after obesity reduction treatment often occurs, and children born to obese women have a higher risk of childhood obesity. STUDY DESIGN SIZE DURATION: A 2-year follow-up of a multicenter, RCT running between 2012 and 2018 was performed. Out of 317 women randomized to weight reduction followed by IVF treatment or IVF treatment-only, 305 remained in the full analysis set. Of these women, 90.5% (276/305) participated in this study. PARTICIPANTS/MATERIALS SETTING METHODS: Nine infertility clinics in Sweden, Denmark and Iceland participated in the RCT. Obese women under 38 years of age having a BMI ≥30 and < 35 kg/m2 were randomized to weight reduction and IVF or IVF-only. In all, 160 patients were randomized to a low calorie diet for 12 weeks and 3-5 weeks of weight stabilization, before IVF and 157 patients to IVF-only. Two years after randomization, the patients filled in a questionnaire regarding current weight, live births and ongoing pregnancies. MAIN RESULTS AND THE ROLE OF CHANCE: 42 additional live births were achieved during the follow-up in the weight reduction and IVF group, and 40 additional live births in the IVF-only group, giving a CLBR, the main outcome of this study, of 57.2% (87/152) and 53.6% (82/153), respectively (P = 0.56; odds ratio (OR) 1.16, 95% CI: 0.74-1.52). Most of the women in the weight reduction and IVF group had regained their pre-study weight after 2 years. The mean weight gain over the 2 years was 8.6 kg, while women in the IVF-only group had a mean weight loss of 1.2 kg. At the 2-year follow-up, the weight standard deviation scores of the children born in the original RCT (index cycle) were 0.218 (1.329) (mean, SD) in the weight reduction and IVF group and - 0.055 (1.271) (mean, SD) in the IVF-only group (P = 0.25; mean difference between groups, 0.327; 95% CI: -0.272 to 0.932). LIMITATIONS REASON FOR CAUTION: All data presented in this follow-up study were self-reported by the participants, which could affect the results. A further limitation is in power for the main outcome. The study is a secondary analysis of a large RCT, where the original power calculation was based on live-birth rate after one cycle and not on CLBR. WIDER IMPLICATIONS OF THE FINDINGS: The follow-up indicates that for women with a BMI ≥30 and < 35 kg/m2 and scheduled for IVF, the weight reduction did not increase their chance of a live birth either in the index cycle or after 2 years. It also shows that even in this highly motivated group, a regain of pre-study weight occurred. STUDY FUNDING/COMPETING INTERESTS: The 2-year follow-up was financed by grants from the Swedish state under the agreement between the Swedish Government and the county councils, the ALF-agreement (ALFGBG-70940 and ALFGBG-77690), Merck AB, Solna, Sweden (an affiliate of Merck KGaA, Darmstadt, Germany), Hjalmar Svensson Foundation. Ms Kluge has nothing to disclose. Dr Bergh has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Einarsson has been reimbursed for lectures for Merck and Ferring. Dr Thurin-Kjellberg reports grants from Merck, and reimbursement for lectures from Merck outside the submitted work. Dr Pinborg has been reimbursed for lectures and other informational activities (Ferring, MSD, Merck, Gedeon Richter). Dr Englund has nothing to disclose. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01566929. SN - 2399-3529 UR - https://www.unboundmedicine.com/medline/citation/31844684/Cumulative_live_birth_rates_after_weight_reduction_in_obese_women_scheduled_for_IVF:_follow_up_of_a_randomized_controlled_trial_ L2 - https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/31844684/ DB - PRIME DP - Unbound Medicine ER -
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