BMI Versus Body Fat Percentage - Which is the Better Predictor of Fertility Outcomes in IVF Cycles?

NCT07765368 | Enrolling By Invitation

• 1 other identifier: 1032377
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective observational cohort study is to evaluate whether body composition measured using bioelectrical impedance analysis (BIA) (including measures of body fat% and visceral fat) serve as a better predictor than body mass index (BMI) of outcomes of in vitro fertilization (IVF) cycles. Participants undergoing IVF will have body composition assessed using a BIA scale prior to treatment, including measurement of body fat percentage. Associations between BMI, BIA-derived body composition measures, and IVF treatment outcomes will be evaluated. Outcomes of interest include ovarian stimulation requirements, number of mature oocytes (eggs) retrieved, number of oocytes fertilized, and number and quality of embryos available for cryopreservation (freezing). Furthermore, ongoing pregnancy and miscarriage rates will be evaluated. The main question is to determine which of either BIA metrics or BMI are a better predictor of ongoing pregnancy or miscarriage rates. Furthermore, we would like to assess if there is an association between BIA metrics or BMI and the response to ovarian stimulation (egg recruitment), number and maturity rate of oocytes retrieved, number of oocytes fertilized and the number and quality of embryos available for cryopreservation. Participants will be asked to step on a BIA scale at the start of their cycle before taking medications to stimulate/recruit oocytes. This scale provides additional information on body fat % and visceral fat % in addition to body weight. The study aims to determine whether measures of adiposity obtained using BIA may provide a more informative assessment of the relationship between body composition and IVF outcomes than BMI alone.

Conditions

Infertility (IVF Patients); BMI; Bioelectrical Impedance Analysis; IVF Outcomes

Keywords

Infertility; IVF; BMI; Bioelectrical Impedance Analysis

Outcome Measures

Primary Outcomes (4)

• Pregnancy Rate

  A positive serum beta hcg measurement at 2 weeks (14 days) post embryo transfer \> 5 mIU/mL.

  Serum blood test measured >/= 14 days post embryo transfer.

• Clinical Pregnancy Rate

  An intrauterine gestational sac documented on an abdominal or transvaginal ultrasound

  A pregnancy located intrauterine on ultrasound performed between 4-9 weeks gestation (dated by embryo transfer).

• Ongoing Pregnancy Rate

  Intrauterine pregnancy with fetal cardiac activity \>/= 7 weeks gestation

  A viable pregnancy identified/measuring >/=7 weeks on routine clinic ultrasound.

• Miscarriage

  Defined as either spontaneous reduction of a once positive serum bhCG on serial documented measurements in the first 7 weeks of gestation or transvaginal ultrasound diagnosis of pregnancy failure using the New England Journal of Medicine Diagnostic Criteria for Nonviable Pregnancy in Early First Trimester (Doubilet et al., 2013)

  From date of positive pregnancy test to < 7 weeks

Secondary Outcomes (4)

• Number of Oocytes Retrieved

  Data point collected routinely at the time of procedure.

• Number of Mature Oocytes

  Data point collected by embryologists routinely on day of egg retrieval procedure.

• Number of Oocytes Fertilized

  Data point routinely collected by embryology the day following the egg retrieval (OPU).

• Number of Cryopreservable Embryos

  Determined by embryologists routinely between days 5-7 post OPU (egg retrieval).

Study Arms (3)

Participants undergoing embryo creation and embryo transfer

These participants are those undergoing IVF and who have at least one embryo transferred during the study period.

Diagnostic Test: Measurement of BIA (Body Fat and Visceral Fat Percentage)

Participants undergoing elective oocyte (egg) freezing.

Participants who undergo oocyte stimulation and cryopreservation (freezing) without fertilization of those eggs during the study period.

Diagnostic Test: Measurement of BIA (Body Fat and Visceral Fat Percentage)

Participants undergoing embryo cryopreservation

Those individuals who have oocytes (eggs) collected and fertilized for cryopreservation (freezing) but who do not have an embryo transferred during the study period.

Diagnostic Test: Measurement of BIA (Body Fat and Visceral Fat Percentage)

Interventions

Measurement of BIA (Body Fat and Visceral Fat Percentage) DIAGNOSTIC_TEST

BIA machines ascertain the flow and resistance of a weak current through the body and apply validated algorithms to provide an estimate of lean body mass. This process takes approximately 30 seconds and will provide estimates of body fat percentage and visceral fat percentage.

Participants undergoing elective oocyte (egg) freezing.; Participants undergoing embryo creation and embryo transfer; Participants undergoing embryo cryopreservation

Eligibility Criteria

• Age: 21 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Consenting patients who are undergoing IVF at a local fertility clinic who do not have an implantable cardiac device.

You may qualify if:

• Patients Undergoing IVF at a Local IVF Clinic

You may not qualify if:

• Patients who use a satellite clinic out of province.
• Patients with Implanted Cardiac Devices

Sponsors & Collaborators

• IWK Health Centre: lead
• Atlantic Fertility: collaborator

Study Sites (1)

Atlantic Fertility

Halifax, Nova Scotia, B3J 3T1, Canada

Location

Related Publications (17)

• Irwin GL, Aguiar Bonfim Cruz AJ, Chandler AJ, Brush CJ, Brown AF. Agreement Between Six Bioelectrical Impedance Analysis Devices and Dual-Energy X-Ray Absorptiometry. J Exerc Nutr. 2025;8(1):17. doi:10.53520/jen2025.103206

  BACKGROUND

• Dechaud H, Anahory T, Reyftmann L, Loup V, Hamamah S, Hedon B. Obesity does not adversely affect results in patients who are undergoing in vitro fertilization and embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2006 Jul;127(1):88-93. doi: 10.1016/j.ejogrb.2005.12.009. Epub 2006 Jan 18.

  PMID: 16417960 BACKGROUND

• Robker RL, Akison LK, Bennett BD, Thrupp PN, Chura LR, Russell DL, Lane M, Norman RJ. Obese women exhibit differences in ovarian metabolites, hormones, and gene expression compared with moderate-weight women. J Clin Endocrinol Metab. 2009 May;94(5):1533-40. doi: 10.1210/jc.2008-2648. Epub 2009 Feb 17.

  PMID: 19223519 BACKGROUND

• Jungheim ES, Moley KH. Current knowledge of obesity's effects in the pre- and periconceptional periods and avenues for future research. Am J Obstet Gynecol. 2010 Dec;203(6):525-30. doi: 10.1016/j.ajog.2010.06.043. Epub 2010 Aug 24.

  PMID: 20739012 BACKGROUND

• Matorras R, Exposito A, Ferrando M, Mendoza R, Larreategui Z, Lainz L, Aranburu L, Andrade F, Aldamiz-Echevarria L, Ruiz-Larrea MB, Ruiz-Sanz JI. Oocytes of women who are obese or overweight have lower levels of n-3 polyunsaturated fatty acids compared with oocytes of women with normal weight. Fertil Steril. 2020 Jan;113(1):53-61. doi: 10.1016/j.fertnstert.2019.08.059.

  PMID: 32033723 BACKGROUND

• Dixon JB, Egger GJ, Finkelstein EA, Kral JG, Lambert GW. 'Obesity paradox' misunderstands the biology of optimal weight throughout the life cycle. Int J Obes (Lond). 2015 Jan;39(1):82-4. doi: 10.1038/ijo.2014.59. Epub 2014 Apr 15.

  PMID: 24732145 BACKGROUND

• Younes G, Kugelman N, Blais I, Lahav-Baratz S, Assaf W, Koifman M, Skvirsky S, Segev Y, Wiener-Magnazi Z, Oron G. Does obesity affect embryo development and quality? A retrospective analysis. Reprod Biomed Online. 2025 Oct;51(4):104753. doi: 10.1016/j.rbmo.2024.104753. Epub 2024 Dec 16.

  PMID: 40848315 BACKGROUND

• AMA: Use of BMI alone is an imperfect clinical measure. June 14, 2023. https://www.ama-assn.org/public-health/chronic-diseases/ama-use-bmi-alone-imperfect-clinical-measure

  BACKGROUND

• Broughton DE, Moley KH. Obesity and female infertility: potential mediators of obesity's impact. Fertil Steril. 2017 Apr;107(4):840-847. doi: 10.1016/j.fertnstert.2017.01.017. Epub 2017 Mar 11.

  PMID: 28292619 BACKGROUND

• Wittemer C, Ohl J, Bailly M, Bettahar-Lebugle K, Nisand I. Does body mass index of infertile women have an impact on IVF procedure and outcome? J Assist Reprod Genet. 2000 Nov;17(10):547-52. doi: 10.1023/a:1026477628723.

  PMID: 11209534 BACKGROUND

• Dokras A, Baredziak L, Blaine J, Syrop C, VanVoorhis BJ, Sparks A. Obstetric outcomes after in vitro fertilization in obese and morbidly obese women. Obstet Gynecol. 2006 Jul;108(1):61-9. doi: 10.1097/01.AOG.0000219768.08249.b6.

  PMID: 16816057 BACKGROUND

• Bellver J, Ayllon Y, Ferrando M, Melo M, Goyri E, Pellicer A, Remohi J, Meseguer M. Female obesity impairs in vitro fertilization outcome without affecting embryo quality. Fertil Steril. 2010 Feb;93(2):447-54. doi: 10.1016/j.fertnstert.2008.12.032. Epub 2009 Jan 26.

  PMID: 19171335 BACKGROUND

• Zhu L, Zhou B, Zhu X, Cheng F, Pan Y, Zhou Y, Wu Y, Xu Q. Association Between Body Mass Index and Female Infertility in the United States: Data from National Health and Nutrition Examination Survey 2013-2018. Int J Gen Med. 2022 Feb 19;15:1821-1831. doi: 10.2147/IJGM.S349874. eCollection 2022.

  PMID: 35221716 BACKGROUND

• Lashen H, Fear K, Sturdee DW. Obesity is associated with increased risk of first trimester and recurrent miscarriage: matched case-control study. Hum Reprod. 2004 Jul;19(7):1644-6. doi: 10.1093/humrep/deh277. Epub 2004 May 13.

  PMID: 15142995 BACKGROUND

• Turner F, Powell SG, Al-Lamee H, Gadhvi A, Palmer E, Drakeley A, Sprung VS, Hapangama D, Tempest N. Impact of BMI on fertility in an otherwise healthy population: a systematic review and meta-analysis. BMJ Open. 2024 Nov 1;14(10):e082123. doi: 10.1136/bmjopen-2023-082123.

  PMID: 39486817 BACKGROUND

• Smigoc K, Wang J, Kallen C BODY MASS INDEX (BMI) THRESHOLDS FOR FERTILITY TREATMENT MARKEDLY DELAY AND OFTEN DENY ACCESS TO CARE Fertility and Sterility, 122, e249-e250

  BACKGROUND

• Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

  PMID: 11234459 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All patients are undergoing IVF for the purpose of oocyte cryopreservation or embryo creation and/or embryo cryopreservation. The biospecimens obtained are for use clinically and not for research purposes. The only information collected regarding these clinical specimens for research purposes are data points regarding the number and quality of these embryos.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Grace Younes, MD

  Atlantic Fertility, IWK Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)