Effects of Plant Extracts on Semen Quality

October 8, 2014 updated by: Jens Fedder, Horsens Hospital

An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial

this is a prospective randomized placebo-controlled double-blinded trial investigating the effect of plant extracts from Alpinia galanga and Punica granatum on human semen quality. The investigators hypothesize that these plant extracts will improve semen quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Horsens, Denmark, 8700
        • Laboratory of Reproductive Biology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Reduced semen quality

Exclusion Criteria:

  • Total count of motile sperm less than 1 million sperm/ejaculate or more than 200 million sperm/ejaculate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Tablets, two in the morning and two in the evening
Active Comparator: Plant extracts
Dietary supplement: Extracts of Punica granatum and Alpinia galanga
Tablets, two in the morning and two in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Count of motile sperm per ejaculate
Time Frame: Each participant is given plant extract for three months with flanking semen analyses.
Each participant is given plant extract for three months with flanking semen analyses.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphology: percentage of morphologically abnormal sperm in the ejaculate
Time Frame: Each participant is given plant extract for three months with flanking semen analyses.
If we find an increase in the primary outcome measure in data from participants receiving plant extracts and not in those receiving placebo tablets, we wish to further investigate whether sperm morphology also improves when consuming the plant extracts, e.g. whether the percentage of abnormal sperm in an ejaculate decreases in the group of participants receiving the active plant extracts
Each participant is given plant extract for three months with flanking semen analyses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horsens Hospital

Collaborators

Videns- og Forskningscenter for Alternativ Behandling

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

October 9, 2014

Last Update Submitted That Met QC Criteria

October 8, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LRB-SU-010

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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