Ignite Creation Date:
2024-05-05 @ 9:52 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00988611
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2009-10-01
Brief Title:
Assisted Reproductive Technology ART Predictors Study
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Novel Predictors of ART Outcomes
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ART
Brief 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 womans 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None