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

Pilot and Feasibility Studies

Research

Xin Sun¹  Jing Tan¹  Sha Tang²  Lanlin Yang²  Sufen Cai²  Fei Gong³  Xiaojuan Wang⁴ 

[1] Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, 610041, Chengdu, Sichuan, China;NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, 610041, Chengdu, Sichuan, China;Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA, 410008, Changsha, Hunan, China;Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA, 410008, Changsha, Hunan, China;Laboratory of Reproductive and Stem Cell Engineering, Key Laboratory of National Health and Family Planning Commission, Central South University, 410008, Changsha, Hunan, China;Department of Epidemiology and Health Statistics, School of Public Health, Central South University, 410008, Changsha, Hunan, China;Clinical Research Center for Reproduction and Genetics in Hunan Province, Reproductive and Genetic Hospital of CITIC-XIANGYA, 410008, Changsha, Hunan, China;

关键词: In vitro fertilisation;    Obesity;    Insulin;    Life style;    Metformin;    Factorial design;   

DOI  :  10.1186/s40814-023-01388-x

 received in 2022-08-08, accepted in 2023-08-29,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundFor infertile women with overweight/obesity and insulin resistance (IR), it is uncertain whether intervention before infertility treatment can improve live birth rate (LBR). We implemented a factorial-design study to explore the effectiveness of lifestyle and metformin interventions. This pilot study aimed to evaluate the feasibility of a definitive study.MethodsWe randomised 80 women without polycystic ovarian syndrome (PCOS) who planned to start their first or second IVF/ICSI treatment with a body mass index ≥ 25 kg/m2 and IR. Participants were randomised (1:1:1:1) into four groups: (A) lifestyle intervention, (B) metformin intervention, (C) lifestyle + metformin intervention, or (D) no intervention. All interventions were performed before IVF/ICSI treatment.ResultsDuring 10 months, 114 women were screened and eligible; 80 were randomised, and 72 received the assigned treatment. The recruitment rate was 70.18% (80/114, 95% CI 61.65%–78.70%). An average of 10 participants were randomised each month. None of the participants crossed over from one group to another. Approximately 93.15% (68/73) of the participants achieved good intervention compliance. Only 77.78% (56/72) of the recruited participants started infertility treatment after achieving the goal of the intervention. All randomised participants completed the follow-up. Mild adverse events after metformin administration were reported in 43.24% (16/37) of the cases, although no serious adverse events related to the interventions occurred. The LBR for groups A + C and B + D were 33.33% (12/36) and 33.33% (12/36) (RR = 1.00, 95%CI:0.52–1.92) (lifestyle intervention effect). The LBR for groups B + C and A + D were 43.24% (16/37) and 22.86% (8/35) (RR = 1.89, 95% CI:0.93–3.86) (metformin intervention effect). There was no evidence for an intervention interaction between lifestyle and metformin. We cannot yet confirm the effects of lifestyle, metformin, or their interaction owing to the insufficient sample size in this pilot study.ConclusionsInstituting a 2 × 2 factorial design randomized controlled trial (RCT) is feasible, as the pilot study showed a high recruitment rate and compliance. There is no evidence that lifestyle or metformin improves live birth, and adequately powered clinical trials are required.Trial registrationclinicaltrials.gov NCT03898037. Registered: April 1, 2019.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

【 图 表 】

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