The Role of Massage in Increasing Total Motile Sperm Count of IUI

April 20, 2022 updated by: Wake Forest University Health Sciences

The Role of Massage in Increasing Total Motile Sperm Count of Intrauterine Insemination

The purpose of this prospective, randomized study, was to determine if neck and shoulder massage performed within 15 minutes of semen sample collection will increase the semen volume, and therefore increase the total motile sperm available for insemination as a result of decreased stress.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Women's Institute at Carolinas Medical Center

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Infertility,
  • initiating clomiphene + IUI therapy
  • signed study consent

Exclusion Criteria:

  • Severe male infertility (baseline semen concentration < 10 million total motile sperm)
  • female bilateral tubal occlusion
  • failure to ovulate with clomiphene
  • failed clomiphene + IUI therapy (three prior cycles with no conception)
  • unable to tolerate clomiphene
  • unable or unwilling to follow study protocol

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Massage
Professional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination.
Behavioral: Massage
NO_INTERVENTION: No massage
Normal protocol for semen collection prior to intrauterine insemination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Motile Sperm Count
Time Frame: 1 month
The primary outcome variable is total motile sperm count, which is determined based on the semen volume, concentration, and motility.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy
Time Frame: 3 months
Pregnancy rate per cycle with intrauterine insemination.
3 months

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

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

December 1, 2005

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (ESTIMATE)

October 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Massage2013

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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