Effects of Plant Extracts on Semen Quality

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Videns og forskningscenter for alternativ behandling (VIFAB )
Information provided by (Responsible Party):
Jens Fedder, Horsens Hospital
ClinicalTrials.gov Identifier:
NCT01357044
First received: May 17, 2011
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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

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


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated 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

  Eligibility

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

Inclusion Criteria:

  • Reduced semen quality (1-20 motile sperm per ejaculate)

Exclusion Criteria:

  • Total count of motile sperm less than 1 million sperm/ejaculate or more than 20 million sperm/ejaculate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357044

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

No publications provided

Responsible Party: Jens Fedder, Professor, Horsens Hospital
ClinicalTrials.gov Identifier: NCT01357044     History of Changes
Other Study ID Numbers: LRB-SU-010
Study First Received: May 17, 2011
Last Updated: December 4, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Horsens Hospital:
Semen quality
Plant extracts

ClinicalTrials.gov processed this record on September 22, 2014