Assisted Reproductive Technology (ART) Predictors Study
Condition: Reproductive Aging
Study type: Observational

Summary: 
      The goals of this research proposal are to further our understanding of the reproductive
      aging process in women and to improve our ability to clinically assess and model reproductive
      aging. Reproductive aging is a continuous process that begins many years prior to menopause.
      Women in their late 30s and early 40s usually maintain normal menstrual function and
      ovulatory status, yet fertility in these women is considerably compromised compared to
      younger women. The primary mechanism of reproductive aging is through the process of ovarian
      primordial follicle (egg) depletion, a process that exhibits considerable variation between
      women. As a result, the age at which an individual begins to experience infertility and
      menstrual cycle changes secondary to follicle depletion also varies significantly and is
      difficult to predict. The clinical assessment of the number of primordial follicles remaining
      in the ovary has traditionally relied upon the measurement of ovarian or pituitary hormones
      such as FSH, estradiol, and inhibin B. Unfortunately, these measures are all indirect and
      poorly sensitive in the assessment of ovarian reserve. More recently, serum levels of
      anti-Müllerian hormone (AMH) and the ovarian antral follicle count have been utilized as
      clinical measures of ovarian reserve. Both have been correlated with chronological age and
      have some predictive power in determining stimulation quantity (the number of oocytes
      obtained at the time of egg-recovery) in in-vitro fertilization (IVF) treatment cycles.
      Reproductive aging in women; however, is more than just the depletion of oocytes from a
      woman's ovaries, but also involves a decline in oocyte quality. The predictive value of these
      clinical markers of ovarian reserve with regards to oocyte quality is unknown. Additionally,
      new tools developed to assess biological aging in other organ systems such as white blood
      cell telomere length and the measurement of advanced glycation end products (AGEs) through
      skin autofluorescence have not been evaluated with respect to the reproductive aging process.
      This proposal seeks to develop better models of normal female reproductive aging by
      identifying novel markers of ovarian reserve and determining their relationship with both
      oocyte quantity and quality obtained during IVF treatment cycles.
    

Detailed description: 
      To test our hypotheses, we will enroll 120 healthy women undergoing ART cycles at OU
      Physicians Reproductive Health.

      Patients undergoing an ART treatment cycle at the OU Physicians Reproductive Health clinic
      will be approached regarding enrollment.

        -  informed consent

        -  collection of baseline demographic data (height, weight, ethnicity, age)

        -  cycle-day 3 measurements of FSH, estradiol, inhibin B, AMH, white-blood cells for
           telomere length assay, and measurement of hemoglobin A1C to control for blood glucose
           levels

        -  AFC as determined by transvaginal ultrasound exam

        -  skin autofluorescence measurement

        -  subjects then undergo IVF as directed by their physician

        -  outcome measures include number of oocytes recovered, peak estradiol, quantity of
           gonadotropins utilized during the course of treatment, and assessment of oocyte quality
           by morphology assessment with light microscopy.
    

Intervention name(s): Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma
Intervention type(s): Other
Intervention description(s): Women undergoing an IVF/ART treatment cycle at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma, age range 18-44 years old
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing an ART treatment cycle at the OU Physicians Reproductive Health clinic
        in Oklahoma City, Oklahoma will be approached regarding enrollment.

        NOTE: Must be willing to travel to Oklahoma City to participate. Need to have the
        transvaginal ultrasound and skin autofluorescence measurement at the OU Physicians
        Reproductive Health Clinic in Oklahoma City, Oklahoma
      
Biospecimen description: 
      Telomere length assay
    
Keywords: Reproductive aging