Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Obesity and Fertility, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To test the pituitary and hypothalamic output, we examined LH secretion (unstimulated and in response to gonadotropin-releasing hormone (GnRH) stimulation) during 8-hour blood sampling studies at 10 min intervals. The primary outcome measure is the change in the average LH pulse amplitude for each patient from baseline to after supplementation.
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 |
What the finished NCT01894581 record still lists
NCT01894581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01894581's enrollment target sits among peer trials
39 806th of 1053 higher than 244 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Metabolic Adaptations to Weight Loss With and Without Exercise
RECRUITING · NA
-
Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial
RECRUITING · NA
-
Tai Chi as a Novel Strategy to Increase Physical Activity Among Adults Pursuing Metabolic and Bariatric Surgery
RECRUITING · NA
-
Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)
RECRUITING · NA
-
SMARTer Weight Loss Management
RECRUITING · NA
-
HealthyTogether: RCT of a Dyadic Weight Management Intervention
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia