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Effects of Dietary Omega-3 Fatty Acids on Reproductive Hormones in Obese Women
Plain-language guide to NCT01894581: not phased non-randomized trial of Gonadorelin, 39 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01894581
- Phase
- not phased
- Status
- completed
- Start
- 2014-07
- Completion (planned or actual)
- 2014-12
- Participants
- 39 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Obesity; Fertility
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Gonadorelin.
Maternal obesity is linked with anovulation, menstrual cycle abnormalities, subfertility, fetal loss, obstetrical complications and congenital anomalies.
It had two arms (groups): Obese Women (experimental) and Normal Weight (active comparator).
The registry classes the interventions as dietary supplement and drug.
Who Took Part
The registry lists 39 actual participants took part.
It was open to women only aged from 18 years up to 42 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-42 at study entry. Regular menstrual cycles every 25-40 days. BMI at least 30 kg/m2 (obese) or between 18.5 and 25 kg/m2 (normal). Prolactin and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening, baseline hemoglobin \>11 gm/dl.
The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: diagnosis of polycystic ovary syndrome (by ultrasound or hyperandrogenic symptoms); fish or seafood allergy or hypersensitivity (e.g., anaphylactic reaction) to omega-3-acid ethyl esters or any component of the formulation; coagulopathy or receiving therapeutic anticoagulation (due to potential for interaction with omega-3 fa).
How the Study Was Run
The set-up was non-randomized, parallel-group and open-label.
The Gonadorelin group and the comparison group ran side by side rather than switching.
Being open-label, the Gonadorelin study did not mask who received what.
It started in 2014-07 with completion listed for 2014-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Change in the Average LH Pulse Amplitude.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of Gonadorelin in 39 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Gonadorelin compound page, all human trials.
Our Notes on the Compound
Gonadorelin: A synthetic version of gonadotropin-releasing hormone (GnRH), the signal that tells the pituitary to release LH and FSH.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.