Reproductive AgingARTNCT00988611
Assisted Reproductive Technology (ART) Predictors Study
An observational study of Reproductive Aging, 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 18 to 44 years, women only
- Conditions the study is for
- Reproductive Aging
- What is being tested?
- Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2016
- 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Gynecological malignancy
- chemotherapy or radiation therapy treatment
- Autoimmune disease
- Prior ovarian surgery
- Ovarian pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73103
About this study
Official title: Novel Predictors of ART Outcomes
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.
Read the 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.
- Conditions
- Reproductive Aging
- Being tested
- Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma
- Keywords
- Reproductive aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women undergoing IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, OklahomaOther
Women undergoing an IVF/ART treatment cycle at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma, age range 18-44 years old
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
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 startSep 2009
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive AgingStudies 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
- 138 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
- NCT00988611
- Sponsor's protocol ID
- ART Predictors Study
- Acronym
- ART
- Status last verified
- Mar 2017
- First submitted
- 1 Oct 2009
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Predictors of ART Outcomes
- ClinicalTrials.gov ID
- NCT00988611
- Acronym / sponsor ID
- ART / ART Predictors Study
- Conditions
- Reproductive Aging
- Keywords
- Reproductive aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (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. 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (4 listed)
- Undergoing an ART treatment cycle
- Age range 18-44 years old
Key exclusion criteria (5 listed)
- Gynecological malignancy
- chemotherapy or radiation therapy treatment
- Autoimmune disease
- Prior ovarian surgery
- Ovarian pathology
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 IVF/ART cycles at OU Physicians Reproductive Health Clinic in Oklahoma City, OklahomaWomen undergoing an IVF/ART treatment cycle at OU Physicians Reproductive Health Clinic in Oklahoma City, Oklahoma, age range 18-44 years old | Other | – |
Primary outcome
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.
Time frame: 2 years
2 secondary outcomes
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.
Time frame: 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.
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 20 Mar 2017.
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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 Aging, 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 4 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 20 Mar 2017. 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?
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. (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 20 Mar 2017.