Fetal Effects of Pre-Pregnancy Lifestyle Interventions in Unexplained Infertility Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This is a cross-sectional comparison study of three maternal and fetal groups. Patients
      studied are women (and their fetus if they conceive) participating in the Reproductive
      Medicine Network's (RMN) FIT-PLESE investigation (funded, the NuPA and PAo arms) compared to
      control mothers who decline the intervention protocols and their fetuses if they conceive.
    

Detailed description: 
      Via participation in the FIT-PLESE study (from the RMN) we will randomize 90 obese women with
      unexplained infertility 1:1 to a lifestyle modification program consisting of nutritionally
      balanced caloric restriction (1200-1500 kcal/d), a gastric lipase inhibitor (Alli) and
      increased physical activity (with a goal of reaching 10K steps/d) (NuPA) versus increased
      physical activity alone (PAo). The pre-pregnancy intervention lasts 16 weeks, with a goal of
      7% weight loss in the NuPA arm. Weight and physical activity are monitored with wireless
      devices (Fitbit Wireless Activity Tracker and Fitbit Aria Wireless Activity Scale,
      respectively). Following the 16 week pre-pregnancy intervention, all randomized couples will
      undergo standard treatment for unexplained infertility, 3 cycles of CC-IUI (requiring ~3
      months). The goal for both treatment groups is to maintain levels of physical activity and
      weight achieved during the pretreatment phase during the empiric infertility treatment phase.
      Women who conceive will be followed throughout pregnancy with the wireless activity monitors
      and wireless scales. Additionally there will be three brief onsite visits during pregnancy
      (at 16, 24 and 32 weeks) for determination of weight, waist circumference, glycemic measures
      (fasting glucose, insulin, and HgbA1C), apolipoprotein lipids, and blood pressure.
      Nutritional intake will be assessed with The Dietary Assessment Questionnaire and Diet
      History Questionnaire II (DHQ II), the instrument chosen by FIT-PLESE investigators
      (http://appliedresearch.cancer.gov/dhq2/). The primary outcomes of FIT-PLESE are the
      live-birth rate, birth weight, gestational age at delivery, and congenital anomaly rate. The
      subject inclusion and exclusion criteria are detailed in the Human Subjects section. There is
      no overlap between the aims of FIT-PLESE and those of the present R21 proposal.

      The three maternal and fetal groups for this proposal are as follows:

      FIT-PLESE participants (University of Pennsylvania Central IRB approved)

      Group 1: Nutritional/Physical Activity (NuPA) Intervention: Obese participants in the
      FIT-PLESE clinical trial randomized to the nutritional restriction /AlliTM/physical activity
      arm that achieve pregnancy.

      Group 2: Physical Activity only (PAo) Intervention: Obese participants in the FIT-PLESE
      clinical trial randomized to the exercise only arm that achieve pregnancy.

      Control group (University of Oklahoma IRB approved) Group 3 (Infertile, non-lifestyle
      intervention controls): Obese women (60) with unexplained infertility who meet the
      inclusion/exclusion criteria for FIT-PLESE but decline participation in the trial and who
      elect to undergo CC-IUI treatment and achieve pregnancy without prior diet and exercise
      interventions.

      We have extensive experience evaluating fetal morphometry from women participating in a
      prospective study designed to assess the relationship between maternal and neonatal adiposity
      (n=77) who have already undergone similar ultrasound and biomarker measurements during
      pregnancy at OUHSC. The data have been collected and are being analyzed. These non-diabetic
      women with uncomplicated pregnancies were evenly distributed between pre-pregnancy BMIs for
      normal weight (BMI <24.9, n=23), overweight (BMI 25-29.9, n=29) or obese (BMI 30>, n=25).
      These women conceived spontaneously and did not undergo diet or exercise intervention (see
      preliminary data below).

      We will assess participants of Group 1, 2 and 3 prior to pregnancy and during each trimester
      at 16, 24, and 32 weeks gestational age for the mothers who conceive. We will then evaluate
      each fetus of those who conceive during each trimester of pregnancy at the same gestational
      ages. We will evaluate newborns within one week of delivery for body composition. All
      participants will have the same inclusion and exclusion criteria.
    

Intervention name(s): Alli-nutritional supplement
Intervention type(s): Dietary Supplement
Intervention description(s): Obese participants in the FIT-PLESE clinical trial randomized to the nutritional restriction /AlliTM/physical activity arm that achieve pregnancy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women that are seen in the OU Reproductive Medicine clinic.
      
Biospecimen description: 
      A de-identified sample of blood will be collected at the time of the baseline visit.