NCT01969825

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4

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

December 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2013

Completed
Last Updated

April 28, 2022

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 22, 2013

Last Update Submit

April 20, 2022

Conditions

Infertility

Keywords

InfertilityIntrauterine inseminationMale factor infertilityMassageTotal motile sperm count

Outcome Measures

Primary Outcomes (1)

  • Total Motile Sperm Count

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

    1 month

Secondary Outcomes (1)

  • Pregnancy

    3 months

Study Arms (2)

Massage

EXPERIMENTAL

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

Behavioral: Massage

No massage

NO INTERVENTION

Normal protocol for semen collection prior to intrauterine insemination.

Interventions

MassageBEHAVIORAL
Massage

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Institute at Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Related Publications (15)

  • 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.

    PMID: 1323572BACKGROUND

  • 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.

    PMID: 8671268BACKGROUND

  • 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.

    PMID: 21452563BACKGROUND

  • 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.

    PMID: 3335259BACKGROUND

  • 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.

    PMID: 9154514BACKGROUND

  • 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.

    PMID: 19052335BACKGROUND

  • 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.

    PMID: 8002116BACKGROUND

  • McGrady AV. Effects of psychological stress on male reproduction: a review. Arch Androl. 1984;13(1):1-7. doi: 10.3109/01485018408987495.

    PMID: 6152527BACKGROUND

  • 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.

    PMID: 23087776BACKGROUND

  • 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.

    PMID: 14717648BACKGROUND

  • 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.

    PMID: 22888364BACKGROUND

  • 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.

    PMID: 19531445BACKGROUND

  • 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.

    PMID: 21147413BACKGROUND

  • 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.

    PMID: 24049209BACKGROUND

  • 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.

    PMID: 22385023BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Massage

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Brad Hurst, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2013

First Posted

October 25, 2013

Study Start

December 1, 2005

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

April 28, 2022

Record last verified: 2013-10

Locations

US(1)