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Infertility (IVF Patients)NCT07765368

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

An observational study of Infertility (IVF Patients) and BMI, run by IWK Health Centre at 1 site in Canada.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 44 years, women onlyHealthy volunteers can take part
What is being tested?
Measurement of BIA (Body Fat and Visceral Fat Percentage)
How many people
200 participants
Where
1 siteCanada
Study dates
25 Jun 2026to Dec 2027
How long will I take part?
1 Year
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • Patients Undergoing IVF at a Local IVF Clinic

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Atlantic Fertility

    Halifax, Nova Scotia, B3J 3T1

Other trials in Canada

About this study

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.

Read more

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.

Read the detailed description

Obesity and increased adiposity have been associated with differences in ovarian response to controlled ovarian stimulation and with reproductive outcomes following in vitro fertilization (IVF) in certain studies with a notable degree of heterogeneity. Body mass index (BMI) is an anthropometric commonly used to estimate adiposity. In reproductive medicine and elsewhere, BMI is used to guide clinical risk assessment, dose gonadotropins for ovarian stimulation, and prognosticate IVF outcomes. With that said, BMI does not distinguish between fat mass and lean body mass and may therefore provide an incomplete assessment of adiposity and body composition.

Bioelectrical impedance analysis (BIA) is a non-invasive method of estimating body composition, including body fat percentage, fat mass, and lean body mass. This prospective observational cohort study will evaluate whether body composition measurements obtained using a BIA scale are associated with ovarian stimulation parameters, embryologic outcomes, and early pregnancy outcomes among patients undergoing IVF. Ultimately, we would like to ascertain which of BMI or BIA are better predictors of IVF success.

Participants will be recruited at the time of planning an IVF treatment cycle. Following informed consent, participants will undergo a standardized BIA measurement prior to or at the beginning of their IVF treatment cycle. Height and weight will also be recorded and used to calculate BMI. The BIA assessment is performed for research purposes and will not be used to determine eligibility for IVF treatment, select the ovarian stimulation protocol, modify medication doses, or otherwise alter the participant's clinical care.

Participants will subsequently undergo IVF treatment according to standard clinical practice. Clinical and laboratory information generated during routine IVF care will be collected from the participant's medical record. Data collected will include demographic and baseline clinical characteristics, ovarian stimulation parameters, embryologic outcomes, and pregnancy outcomes.

The study will examine relationships between BMI and BIA-derived measures of body composition and IVF outcomes. Outcomes of interest will include measures of ovarian response, such as total gonadotropin requirement and number of oocytes retrieved; embryologic outcomes, including mature oocyte yield and number and quality of embryos available for cryopreservation; and reproductive outcomes, including biochemical pregnancy, clinical pregnancy, ongoing pregnancy, and early pregnancy loss, where applicable.

BIA-derived measures, particularly body fat percentage, will be evaluated as continuous variables and compared with BMI with respect to their associations with IVF outcomes. Analyses will also consider relevant participant characteristics that may influence IVF outcomes, including age, ethnicity, smoking status, ovarian reserve testing, and other pre-specified demographic and clinical factors.

The primary objective of the study is to determine whether BIA-derived measures of adiposity and body composition are associated with IVF treatment outcomes and whether these measures provide additional or improved predictive information compared with BMI alone.

The study is observational. Participants will not be assigned to different treatment groups on the basis of BMI, body fat percentage, or other BIA measurements. All participants undergoing IVF who meet the inclusion criteria are invited to participate and will receive IVF treatment according to usual clinical practice. The study therefore evaluates naturally occurring variation in BMI and body composition as exposures of interest rather than testing an intervention.

The findings from this study may help determine whether direct assessment of body composition provides clinically meaningful information beyond BMI when evaluating the relationship between adiposity and IVF outcomes. This information may inform future research examining the role of body composition in fertility treatment and potentially improve characterization of metabolic and reproductive risk among patients undergoing IVF.

Being tested
Measurement of BIA (Body Fat and Visceral Fat Percentage)
Keywords
Infertility, IVF, BMI, Bioelectrical Impedance Analysis
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Measurement of BIA (Body Fat and Visceral Fat Percentage)Diagnostic test

    Participants are asked to step on a BIA machine to collect data such as weight, lean body mass, body fat percentage and visceral fat percentage.

Study groups in NCT07765368
Study groupRoleWhat they receive
Participants undergoing embryo creation and embryo transferThese participants are those undergoing IVF and who have at least one embryo transferred during the study period.
Receives: 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.
Receives: Diagnostic Test: Measurement of BIA (Body Fat and Visceral Fat Percentage)
Participants undergoing embryo cryopreservationThose individuals who have oocytes (eggs) collected and fertilized for cryopreservation (freezing) but who do not have an embryo transferred during the study period.
Receives: Diagnostic Test: Measurement of BIA (Body Fat and Visceral Fat Percentage)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy Rate

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

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

  2. Clinical Pregnancy Rate

    An intrauterine gestational sac documented on an abdominal or transvaginal ultrasound

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

  3. Ongoing Pregnancy Rate

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

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

  4. 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)

    Measured: From date of positive pregnancy test to < 7 weeks

Secondary outcomes (4)
  1. Number of Oocytes Retrieved

    The number of oocytes (eggs) obtained at the oocyte pick-up (OPU) retrieval procedure.

    Measured: Data point collected routinely at the time of procedure.

  2. Number of Mature Oocytes

    The number of mature oocytes (eggs) obtained at OPU (egg retrieval). That is, those eggs arrested in metaphase II that can be visualized microscopically as having a first polar body.

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

  3. Number of Oocytes Fertilized

    The number of mature oocytes that were successfully fertilized by either conventional IVF or Intra-Cytoplasmic Sperm Injection (ICSI) procedure.

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

  4. Number of Cryopreservable Embryos

    The number of blastocysts post OPU which are of adequate grade and quality to cryopreserve (freeze). That is, the inner cell mass or trophectoderm has been assigned a grade C or better by trained embryologists.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2026
  2. Study start25 Jun 2026
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT07765368
Sponsor's protocol ID
1032377
Status last verified
Aug 2026
First submitted
11 Aug 2026
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The sharing of IPD was not included in the original ethics application/approval for this project.

Publications

  • 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

  • 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.

    PubMed 16417960
  • 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.

    PubMed 19223519
  • 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.

    PubMed 20739012
  • 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.

    PubMed 32033723
  • 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.

    PubMed 24732145
  • 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.

    PubMed 40848315
  • 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

  • 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.

    PubMed 28292619
  • 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.

    PubMed 11209534
  • 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.

    PubMed 16816057
  • 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.

    PubMed 19171335
  • 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.

    PubMed 35221716
  • 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.

    PubMed 15142995
  • 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.

    PubMed 39486817

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility (IVF Patients) and BMI, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnancy Rate (time frame: Serum blood test measured >/= 14 days post embryo transfer.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07765368, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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