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NCT02122211 · ClinicalTrials.gov registry record · Phase 1

Choline Dehydrogenase and Sperm Function: Effects of Betaine

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
6
Enrollment target

NCT02122211: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT02122211 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02122211, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
6 participants
Enrollment target

Study Summary

The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.

Primary Outcome

Assessed using Computer-Aided Sperm Analysis methodology

Interventions

  • DRUG Betaine supplement

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2014-04
Est. Completion 2016-07
Phase Phase 1

What the finished NCT02122211 record still lists

NCT02122211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 1 intervention - of which Betaine supplement is the first listed.

NCT02122211 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02122211 about?

NCT02122211 is a clinical study titled "Choline Dehydrogenase and Sperm Function: Effects of Betaine". The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found nor...

What is the current status of trial NCT02122211?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2014-04. Estimated completion is 2016-07.

What interventions are being tested in trial NCT02122211?

The interventions under investigation include: Betaine supplement (DRUG).

Who is sponsoring clinical trial NCT02122211?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02122211's enrollment target sits among peer trials

6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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

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Source: ClinicalTrials.gov NCT02122211, the US trial registry maintained by the National Library of Medicine. NCT02122211 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.