BMI Versus Body Fat Percentage - Which is the Better Predictor of Fertility Outcomes in IVF Cycles?
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pregnancy Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 44 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients Undergoing IVF at a Local IVF Clinic
排除标准
- •Patients who use a satellite clinic out of province.
- •Patients with Implanted Cardiac Devices
研究组 & 干预措施
Participants undergoing elective oocyte (egg) freezing.
Participants who undergo oocyte stimulation and cryopreservation (freezing) without fertilization of those eggs during the study period.
干预措施: Measurement of BIA (Body Fat and Visceral Fat Percentage) (Diagnostic Test)
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.
干预措施: Measurement of BIA (Body Fat and Visceral Fat Percentage) (Diagnostic Test)
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.
干预措施: Measurement of BIA (Body Fat and Visceral Fat Percentage) (Diagnostic Test)
结局指标
主要结局
Pregnancy Rate
时间窗: Serum blood test measured >/= 14 days post embryo transfer.
A positive serum beta hcg measurement at 2 weeks (14 days) post embryo transfer \> 5 mIU/mL.
Clinical Pregnancy Rate
时间窗: A pregnancy located intrauterine on ultrasound performed between 4-9 weeks gestation (dated by embryo transfer).
An intrauterine gestational sac documented on an abdominal or transvaginal ultrasound
Ongoing Pregnancy Rate
时间窗: A viable pregnancy identified/measuring >/=7 weeks on routine clinic ultrasound.
Intrauterine pregnancy with fetal cardiac activity \>/= 7 weeks gestation
Miscarriage
时间窗: From date of positive pregnancy test to < 7 weeks
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)
次要结局
- 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).)
研究者
Nicole MacEachren
Principle Investigator
IWK Health Centre
