NCT01357044

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1.6 years

First QC Date

May 17, 2011

Last Update Submit

October 8, 2014

Conditions

Poor Semen Quality

Keywords

Semen qualityPlant extracts

Outcome Measures

Primary Outcomes (1)

  • Count of motile sperm per ejaculate

    Each participant is given plant extract for three months with flanking semen analyses.

Secondary Outcomes (1)

  • Morphology: percentage of morphologically abnormal sperm in the ejaculate

    Each participant is given plant extract for three months with flanking semen analyses.

Study Arms (2)

Plant extracts

ACTIVE COMPARATOR
Dietary Supplement: Extracts of Punica granatum and Alpinia galanga

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Extracts of Punica granatum and Alpinia galangaDIETARY_SUPPLEMENT

Tablets, two in the morning and two in the evening

Plant extracts
PlaceboDIETARY_SUPPLEMENT

Tablets, two in the morning and two in the evening

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Reduced semen quality

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Reproductive Biology

Horsens, 8700, Denmark

Location

Related Publications (1)

  • Fedder MD, Jakobsen HB, Giversen I, Christensen LP, Parner ET, Fedder J. An extract of pomegranate fruit and galangal rhizome increases the numbers of motile sperm: a prospective, randomised, controlled, double-blinded trial. PLoS One. 2014 Oct 2;9(9):e108532. doi: 10.1371/journal.pone.0108532. eCollection 2014.

    PMID: 25275520DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 20, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)