Assisted Reproductive Technology (ART) Predictors Study

NCT00988611 | Completed

• 1 other identifier: ART Predictors Study
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Reproductive Aging

Keywords

Reproductive aging

Outcome Measures

Primary Outcomes (1)

• Determine whether newly described measures of biological age and oxidative stress (white-blood cell telomere length and AGEs measured by skin autofluorescence) are correlated with stimulation quantity (number of oocytes retrieved) in IVF cycles.

  2 years

Secondary Outcomes (2)

• Determine whether white blood cell telomere length and AGEs measured by skin autofluorescence are correlated with oocyte quality in IVF cycles after adjustment for chronological age.

  2 years

• Determine whether established clinical markers of quantitative ovarian reserve (AMH, AFC, FSH, and inhibin B) are correlated with oocyte quality in IVF cycles after adjustment for chronological age.

  2 years

Interventions

Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma OTHER

Women undergoing an IVF/ART treatment cycle at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma, age range 18-44 years old

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Undergoing an ART treatment cycle
• Age range 18-44 years old
• 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
• NOTE: Study will not pay for ART/IVF treatment.

You may not qualify if:

• Gynecological malignancy
• chemotherapy or radiation therapy treatment
• Autoimmune disease
• Prior ovarian surgery
• Ovarian pathology

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73103, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Telomere length assay

Study Officials

• Karl R Hansen, MD, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)