Clinical trial NCT01969825: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Infertility
Intrauterine insemination
Male factor infertility
Massage
Total motile sperm count
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Total Motile Sperm Count
timeFrame: 1 month
Secondary outcomes:
measure: Pregnancy
timeFrame: 3 months
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Women's Institute at Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Brad Hurst, MD
role: PRINCIPAL_INVESTIGATOR
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