Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Plant Extracts on Semen Quality

This study has been completed.
Videns og forskningscenter for alternativ behandling (VIFAB )
Information provided by (Responsible Party):
Jens Fedder, Horsens Hospital Identifier:
First received: May 17, 2011
Last updated: October 8, 2014
Last verified: October 2014

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.

Condition Intervention
Poor Semen Quality
Dietary Supplement: Extracts of Punica granatum and Alpinia galanga
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Extract of Pomegranate Fruit and Galangal Rhizome Increases the Numbers of Motile Sperm: A Prospective, Randomised, Controlled, Double-Blinded Trial

Further study details as provided by Horsens Hospital:

Primary Outcome Measures:
  • Count of motile sperm per ejaculate [ Time Frame: Each participant is given plant extract for three months with flanking semen analyses. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morphology: percentage of morphologically abnormal sperm in the ejaculate [ Time Frame: Each participant is given plant extract for three months with flanking semen analyses. ] [ Designated as safety issue: No ]
    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

Enrollment: 70
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plant extracts Dietary Supplement: Extracts of Punica granatum and Alpinia galanga
Tablets, two in the morning and two in the evening
Placebo Comparator: Placebo Dietary Supplement: Placebo
Tablets, two in the morning and two in the evening


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01357044

Laboratory of Reproductive Biology
Horsens, Denmark, 8700
Sponsors and Collaborators
Horsens Hospital
Videns og forskningscenter for alternativ behandling (VIFAB )
  More Information

No publications provided by Horsens Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jens Fedder, Professor, Horsens Hospital Identifier: NCT01357044     History of Changes
Other Study ID Numbers: LRB-SU-010
Study First Received: May 17, 2011
Last Updated: October 8, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Horsens Hospital:
Semen quality
Plant extracts processed this record on February 27, 2015