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

NCT ID: NCT01969825

Last Updated: 2022-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Massage

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

Group Type EXPERIMENTAL

Massage

Intervention Type BEHAVIORAL

No massage

Normal protocol for semen collection prior to intrauterine insemination.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Massage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brad Hurst, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Women's Institute at Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 1323572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8671268 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21452563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3335259 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9154514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19052335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8002116 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 6152527 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23087776 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14717648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22888364 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19531445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21147413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24049209 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22385023 (View on PubMed)

Other Identifiers

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Massage2013

Identifier Type: -

Identifier Source: org_study_id

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