- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988611
Assisted Reproductive Technology (ART) Predictors Study (ART)
Novel Predictors of ART Outcomes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- University of Oklahoma Health Sciences Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Gynecological malignancy
- chemotherapy or radiation therapy treatment
- Autoimmune disease
- Prior ovarian surgery
- Ovarian pathology
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karl R Hansen, MD, PhD, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ART Predictors Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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