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NCT01894581 · ClinicalTrials.gov registry record · NA
Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
A NA study of Obesity and Fertility, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT01894581 is a NA study of Obesity and Fertility that has completed, run by University of Colorado, Denver. The registered enrollment target is 39 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01894581, a NA study of Obesity and Fertility, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
The United States has the highest prevalence of obesity among all countries surveyed in 2012 by the Organization for Economic Cooperation and Development. Maternal obesity is linked with anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical complications and congenital anomalies. Changes in reproductive hormones and diminished oocyte quality have also been demonstrated. A gap of knowledge exists as the mechanisms underlying these harmful effects are poorly understood and no specific treatments exist. This proposal will test the hypothesis that dietary omega-3 fatty acids (FA) will improve the output of hypothalamicpituitary- ovarian axis in obese women. The investigators will perform paired assessments before and after supplementation in 10 obese and 10 normal weight women. To test the pituitary and hypothalamic output, the investigators will examine the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) responsiveness during frequent blood sampling. To test the corpus luteum function, the investigators will examine urinary reproductive hormones (E1c, estrone conjugates, and pregnanediol glucuronide (Pdg)) over an entire menstrual cycle. The investigators ultimate goal is to collect preliminary data for an adequately powered randomized control trial.
Interventions
- DRUG GnRH
- DIETARY_SUPPLEMENT LOVAZA
Study Locations (1)
Colorado
- University of Colorado Denver Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894581
The ClinicalTrials.gov registry entry for NCT01894581 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which GnRH is the first listed.
NCT01894581 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT01894581 about?
NCT01894581 is a clinical study titled "Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women". The United States has the highest prevalence of obesity among all countries surveyed in 2012 by the Organization for Economic Cooperation and Development. Maternal obesity is linked with anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical complications and congenital an...
What is the current status of trial NCT01894581?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2014-07. Estimated completion is 2014-12.
What conditions does trial NCT01894581 study?
This clinical trial studies the following conditions: Obesity, Fertility.
What interventions are being tested in trial NCT01894581?
The interventions under investigation include: GnRH (DRUG), LOVAZA (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01894581?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01894581 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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