Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01969825
Other study ID # Massage2013
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2005
Est. completion date December 2006

Study information

Verified date October 2013
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Massage


Locations

Country Name City State
United States Women's Institute at Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (15)

Collodel G, Moretti E, Fontani V, Rinaldi S, Aravagli L, Saragò G, Capitani S, Anichini C. Effect of emotional stress on sperm quality. Indian J Med Res. 2008 Sep;128(3):254-61. — View Citation

Cui KH. The effect of stress on semen reduction in the marmoset monkey (Callithrix jacchus). Hum Reprod. 1996 Mar;11(3):568-73. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

McGrady AV. Effects of psychological stress on male reproduction: a review. Arch Androl. 1984;13(1):1-7. — View Citation

Moyer CA, Rounds J, Hannum JW. A meta-analysis of massage therapy research. Psychol Bull. 2004 Jan;130(1):3-18. — View 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. Review. — View 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. — View 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. Epub 2012 Sep 26. — View 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. — View Citation

* Note: There are 15 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pregnancy Pregnancy rate per cycle with intrauterine insemination. 3 months
See also
  Status Clinical Trial Phase
Completed NCT03607409 - Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
Recruiting NCT02312076 - GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles Phase 4
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Completed NCT03287479 - Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®) N/A
Terminated NCT03522350 - Randomized Trial Comparing EmbryoScope With EmbryoScope+. N/A
Completed NCT04496284 - Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen N/A
Completed NCT03623659 - pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts N/A
Completed NCT03895099 - New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors Phase 3
Active, not recruiting NCT04142112 - Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation N/A
Completed NCT03152643 - Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer N/A
Recruiting NCT03683771 - Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
Recruiting NCT03161119 - Comparing Two Different Embryo Transfer Catheters N/A
Completed NCT04108039 - Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles. N/A
Completed NCT03678610 - Handling Medium for ICSI With Ionomycin and Latrunculin A N/A
Completed NCT03678584 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA) N/A
Completed NCT03678818 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA) N/A
Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
Completed NCT03677492 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD) N/A
Completed NCT03678571 - Oocyte Vitrification Aided With Latrunculin A N/A
Completed NCT03678558 - Oocyte Vitrification Aided With Cytochalasin B N/A