Reproductive AgeNCT00989183
Lifestyle Factors Study
An observational study of Reproductive Age and Oophorectomy for Benign Indications, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reproductive Age, Oophorectomy for Benign Indications
- What is being tested?
- Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2009to 27 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Gynecological malignancy
- Chemotherapy or radiation treatment
- Autoimmune disease
- Prior ovarian surgery
- Subjects with ovarian pathology such as polycystic ovaries, endometrioma, dermoid
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Lifestyle Factors and Their Impact on Ovarian Reserve
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.
Read the 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
- Being tested
- Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma
- Keywords
- Ovaries, Reproductive Age, Oophorectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, OklahomaOther
Women undergoing an elective bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma Age range 21-55 years old
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Determine whether white blood cell telomere length and AGE measured by skin autofluorescence are correlated with ovarian PF number.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study start19 Aug 2009
- Primary completion27 Aug 2020
- Study completion27 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karl R Hansen, MD, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989183
- Sponsor's protocol ID
- 1964
- Status last verified
- Mar 2021
- First submitted
- 1 Oct 2009
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Factors and Their Impact on Ovarian Reserve
- ClinicalTrials.gov ID
- NCT00989183
- Acronym / sponsor ID
- 1964
- Keywords
- Ovaries, Reproductive Age, Oophorectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 19 Aug 2009 (actual)
- Primary completion
- 27 Aug 2020 (actual)
- Study completion
- 27 Aug 2020 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Undergoing gynecologic operations in which a bilateral or unilateral oophorectomy is performed at OU Medical Center, Oklahoma City
- 21-55 years old
Key exclusion criteria (5 listed)
- Gynecological malignancy
- Chemotherapy or radiation treatment
- Autoimmune disease
- Prior ovarian surgery
- Subjects with ovarian pathology such as polycystic ovaries, endometrioma, dermoid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women undergoing a bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, OklahomaWomen undergoing an elective bilateral or unilateral oophorectomy at OU Medical Center, Oklahoma City, Oklahoma Age range 21-55 years old | Other | – |
Primary outcome
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
1 secondary outcome
Determine whether white blood cell telomere length and AGE measured by skin autofluorescence are correlated with ovarian PF number.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl R Hansen, MD, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Age and Oophorectomy for Benign Indications, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.