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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Massage
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility focused on measuring Infertility, Intrauterine insemination, Male factor infertility, Massage, Total motile sperm count

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Women's Institute at Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Massage

No massage

Arm Description

Professional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination.

Normal protocol for semen collection prior to intrauterine insemination.

Outcomes

Primary Outcome Measures

Total Motile Sperm Count
The primary outcome variable is total motile sperm count, which is determined based on the semen volume, concentration, and motility.

Secondary Outcome Measures

Pregnancy
Pregnancy rate per cycle with intrauterine insemination.

Full Information

First Posted
October 22, 2013
Last Updated
April 20, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01969825
Brief Title
The Role of Massage in Increasing Total Motile Sperm Count of IUI
Official Title
The Role of Massage in Increasing Total Motile Sperm Count of Intrauterine Insemination
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Intrauterine insemination, Male factor infertility, Massage, Total motile sperm count

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Massage
Arm Type
Experimental
Arm Description
Professional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination.
Arm Title
No massage
Arm Type
No Intervention
Arm Description
Normal protocol for semen collection prior to intrauterine insemination.
Intervention Type
Behavioral
Intervention Name(s)
Massage
Primary Outcome Measure Information:
Title
Total Motile Sperm Count
Description
The primary outcome variable is total motile sperm count, which is determined based on the semen volume, concentration, and motility.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Pregnancy
Description
Pregnancy rate per cycle with intrauterine insemination.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brad Hurst, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Institute at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
1323572
Citation
Gerhard I, Lenhard K, Eggert-Kruse W, Runnebaum B. Clinical data which influence semen parameters in infertile men. Hum Reprod. 1992 Jul;7(6):830-7. doi: 10.1093/oxfordjournals.humrep.a137745.
Results Reference
background
PubMed Identifier
8671268
Citation
Cui KH. The effect of stress on semen reduction in the marmoset monkey (Callithrix jacchus). Hum Reprod. 1996 Mar;11(3):568-73. doi: 10.1093/humrep/11.3.568.
Results Reference
background
PubMed Identifier
21452563
Citation
Jurewicz J, Hanke W, Sobala W, Merecz D, Radwan M. [The effect of stress on the semen quality]. Med Pr. 2010;61(6):607-13. Polish.
Results Reference
background
PubMed Identifier
3335259
Citation
Giblin PT, Poland ML, Moghissi KS, Ager JW, Olson JM. Effects of stress and characteristic adaptability on semen quality in healthy men. Fertil Steril. 1988 Jan;49(1):127-32. doi: 10.1016/s0015-0282(16)59663-0.
Results Reference
background
PubMed Identifier
9154514
Citation
Fenster L, Katz DF, Wyrobek AJ, Pieper C, Rempel DM, Oman D, Swan SH. Effects of psychological stress on human semen quality. J Androl. 1997 Mar-Apr;18(2):194-202.
Results Reference
background
PubMed Identifier
19052335
Citation
Collodel G, Moretti E, Fontani V, Rinaldi S, Aravagli L, Sarago G, Capitani S, Anichini C. Effect of emotional stress on sperm quality. Indian J Med Res. 2008 Sep;128(3):254-61.
Results Reference
background
PubMed Identifier
8002116
Citation
De Souza MJ, Arce JC, Pescatello LS, Scherzer HS, Luciano AA. Gonadal hormones and semen quality in male runners. A volume threshold effect of endurance training. Int J Sports Med. 1994 Oct;15(7):383-91. doi: 10.1055/s-2007-1021075.
Results Reference
background
PubMed Identifier
6152527
Citation
McGrady AV. Effects of psychological stress on male reproduction: a review. Arch Androl. 1984;13(1):1-7. doi: 10.3109/01485018408987495.
Results Reference
background
PubMed Identifier
23087776
Citation
Sefton JM, Yarar C, Berry JW. Six weeks of massage therapy produces changes in balance, neurological and cardiovascular measures in older persons. Int J Ther Massage Bodywork. 2012;5(3):28-40. doi: 10.3822/ijtmb.v5i3.181. Epub 2012 Sep 26.
Results Reference
background
PubMed Identifier
14717648
Citation
Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18. doi: 10.1037/0033-2909.130.1.3.
Results Reference
background
PubMed Identifier
22888364
Citation
Hodgson NA, Lafferty D. Reflexology versus Swedish Massage to Reduce Physiologic Stress and Pain and Improve Mood in Nursing Home Residents with Cancer: A Pilot Trial. Evid Based Complement Alternat Med. 2012;2012:456897. doi: 10.1155/2012/456897. Epub 2012 Jul 24.
Results Reference
background
PubMed Identifier
19531445
Citation
Reindollar RH, Regan MM, Neumann PJ, Levine BS, Thornton KL, Alper MM, Goldman MB. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial. Fertil Steril. 2010 Aug;94(3):888-99. doi: 10.1016/j.fertnstert.2009.04.022. Epub 2009 Jun 16.
Results Reference
background
PubMed Identifier
21147413
Citation
Moyer CA, Seefeldt L, Mann ES, Jackley LM. Does massage therapy reduce cortisol? A comprehensive quantitative review. J Bodyw Mov Ther. 2011 Jan;15(1):3-14. doi: 10.1016/j.jbmt.2010.06.001. Epub 2010 Jul 2.
Results Reference
background
PubMed Identifier
24049209
Citation
Thirthalli J, Naveen GH, Rao MG, Varambally S, Christopher R, Gangadhar BN. Cortisol and antidepressant effects of yoga. Indian J Psychiatry. 2013 Jul;55(Suppl 3):S405-8. doi: 10.4103/0019-5545.116315.
Results Reference
background
PubMed Identifier
22385023
Citation
Huang W, Taylor A, Howie J, Robinson N. Is the diurnal profile of salivary cortisol concentration a useful marker for measuring reported stress in acupuncture research? A randomized controlled pilot study. J Altern Complement Med. 2012 Mar;18(3):242-50. doi: 10.1089/acm.2010.0325. Epub 2012 Mar 2.
Results Reference
background

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

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