InfertilityPhase 4NCT01969825
The Role of Massage in Increasing Total Motile Sperm Count of IUI
A Phase 4 study testing Massage in people with Infertility, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Infertility,
- initiating clomiphene + IUI therapy
- signed study consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Women's Institute at Carolinas Medical Center
Charlotte, North Carolina, 28204
About this study
Official title: 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.
- Conditions
- Infertility
- Being tested
- Massage
- Keywords
- Infertility, Intrauterine insemination, Male factor infertility, Massage, Total motile sperm count
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MassageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Massage | Experimental | Professional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination. Receives: Behavioral: Massage |
| No massage | No intervention | Normal protocol for semen collection prior to intrauterine insemination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Motile Sperm Count
The primary outcome variable is total motile sperm count, which is determined based on the semen volume, concentration, and motility.
Measured: 1 month
Secondary outcomes (1)
Pregnancy
Pregnancy rate per cycle with intrauterine insemination.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startDec 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brad Hurst, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969825
- Sponsor's protocol ID
- Massage2013
- Status last verified
- Oct 2013
- First submitted
- 22 Oct 2013
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 1323572Cui 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.
PubMed 8671268Jurewicz 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.
PubMed 21452563Giblin 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.
PubMed 3335259Fenster 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.
PubMed 9154514Collodel 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.
PubMed 19052335De 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.
PubMed 8002116McGrady AV. Effects of psychological stress on male reproduction: a review. Arch Androl. 1984;13(1):1-7. doi: 10.3109/01485018408987495.
PubMed 6152527Sefton 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.
PubMed 23087776Moyer 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.
PubMed 14717648Hodgson 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.
PubMed 22888364Reindollar 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.
PubMed 19531445Moyer 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.
PubMed 21147413Thirthalli 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.
PubMed 24049209Huang 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.
PubMed 22385023
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Massage in Increasing Total Motile Sperm Count of Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT01969825
- Acronym / sponsor ID
- Massage2013
- Conditions
- Infertility
- Keywords
- Infertility, Intrauterine insemination, Male factor infertility, Massage, Total motile sperm count
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage | Experimental | Behavioral: MassageProfessional Swedish massage less than 15 minutes prior to semen collection for intrauterine insemination. |
| No massage | No intervention | –Normal protocol for semen collection prior to intrauterine insemination. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Infertility,
- initiating clomiphene + IUI therapy
- signed study consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage | Behavioural | Massage |
Primary outcome
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 secondary outcome
Pregnancy
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 1323572Gerhard 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.
- Background: PubMed 8671268Cui 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.
- Background: PubMed 21452563Jurewicz 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.
- Background: PubMed 3335259Giblin 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.
- Background: PubMed 9154514Fenster 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.
- Background: PubMed 19052335Collodel 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.
- Background: PubMed 8002116De 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.
- Background: PubMed 6152527McGrady AV. Effects of psychological stress on male reproduction: a review. Arch Androl. 1984;13(1):1-7. doi: 10.3109/01485018408987495.
- Background: PubMed 23087776Sefton 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.
- Background: PubMed 14717648Moyer 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.
- Background: PubMed 22888364Hodgson 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.
- Background: PubMed 19531445Reindollar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Hurst, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Massage in people with Infertility, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Motile Sperm Count (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01969825, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.