Effects of Plant Extracts on Semen Quality

Poor Semen Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357044
• Other study ID #: LRB-SU-010
• Status: Completed
• Phase: N/A
• First received: May 17, 2011
• Last updated: October 8, 2014
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: October 2014
• Source: Horsens Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Poor Semen Quality

Intervention

Dietary Supplement:
• Extracts of Punica granatum and Alpinia galanga
Tablets, two in the morning and two in the evening
• Placebo
Tablets, two in the morning and two in the evening

Locations

Country	Name	City	State
Denmark	Laboratory of Reproductive Biology	Horsens

Sponsors (2)

Lead Sponsor	Collaborator
Horsens Hospital	Videns- og Forskningscenter for Alternativ Behandling

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of motile sperm per ejaculate		Each participant is given plant extract for three months with flanking semen analyses.	No
Secondary	Morphology: percentage of morphologically abnormal sperm in the ejaculate	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.	No