Lifestyle Factors Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00989183
First received: October 1, 2009
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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. Multiple studies have investigated the impact of lifestyle choices (tobacco use, oral contraceptives, BMI, alcohol use, and parity) on reproductive lifespan by correlating the impact of these exposures with the age of spontaneous menopause. Although occasionally in agreement, many of these studies report contradictory findings. Alcohol use either delays or has no effect upon the age of spontaneous menopause. Similarly, oral contraceptive pill use has been suggested to both accelerate and delay the onset of menopause. The most consistent findings regarding the impact of these factors is an acceleration in the age of menopause by 1-2 years in smokers. Given the lack of consistent findings in these investigations, the exact impact of lifestyle factors on reproductive age is currently unknown. Nevertheless, the magnitude of such exposures in the U.S. population is considerable, with 19% of adult women using oral contraceptives and 19.2% current smokers according to recent statistics. This proposal seeks to develop better models of normal female reproductive aging through anatomical studies investigating the impact of lifestyle choices on ovarian primordial follicle number. A secondary aim is to determine the relationship between newly described markers developed to assess biological aging in other organ systems (white blood cell telomere length and the measurement of advanced glycation end products (AGEs) through skin autofluorescence) and reproductive age.


Condition Intervention
Reproductive Age
Oophorectomy for Benign Indications
Other: Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Lifestyle Factors and Their Impact on Ovarian Reserve

Resource links provided by NLM:


Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • To determine the impact of lifestyle choices (body-mass index, smoking, oral contraceptive use, and ethanol use) on ovarian primordial follicle (PF) number with the goal of incorporating these parameters into our model of reproductive aging in women. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine whether white blood cell telomere length and AGE measured by skin autofluorescence are correlated with ovarian PF number. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Telomere length assay


Estimated Enrollment: 65
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma
    Women undergoing an elective bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma Age range 21-55 years old
Detailed Description:

In order to test the hypotheses, we will obtain whole ovaries (single or pairs) from 65 healthy females between the ages of 21 and 55 undergoing surgical oophorectomy at OU Medical Center for benign indications.

  • informed consent
  • collection of baseline demographic data (height, weight, ethnicity, age)
  • completion of structured interview to obtain information regarding oral contraceptive, ethanol, tobacco use and socioeconomic status
  • Measurements of FSH, estradiol, inhibin B, AMH, white-blood cells for telomere length, measurement of hemoglobin A1C to control for blood glucose levels
  • AFC as determined by transvaginal ultrasound exam
  • skin autofluorescence measurement
  • subjects then undergo surgery with their primary care gynecologist
  • determination of ovarian PF number by modern morphometric methods
  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

We will obtain whole ovaries (single or pairs) from 65 healthy females between the ages of 21 and 55 undergoing surgical oophorectomy for benign indications at the OU Medical Center, Oklahoma City, Oklahoma.

*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.

Criteria

Inclusion Criteria:

  • Undergoing gynecologic operations in which a bilateral or unilateral oophorectomy is performed at OU Medical Center, Oklahoma City
  • 21-55 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.

Exclusion Criteria:

  • Gynecological malignancy
  • Chemotherapy or radiation treatment
  • Autoimmune disease
  • Prior ovarian surgery
  • Subjects with ovarian pathology such as polycystic ovaries, endometrioma, dermoid
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989183

Locations
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Karl R Hansen, MD, PhD University of Oklahoma
  More Information

No publications provided

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00989183     History of Changes
Other Study ID Numbers: Lifestyle Factors Study
Study First Received: October 1, 2009
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Ovaries
Reproductive Age
Oophorectomy

ClinicalTrials.gov processed this record on August 28, 2014