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NCT01999959 Clinical Trial

Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01999959
Other study ID # 3061750
Secondary ID
Status Completed
Phase Phase 2
First received November 26, 2013
Last updated November 26, 2013
Start date January 2010
Est. completion date June 2011

Study information
Verified date November 2013
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority Republic of Turkey, Ministry of Health: Turkey
Study type Interventional

Clinical Trial Summary

To demonstrate a possible beneficial impact of pertubation we designed a randomized prospective study, in which uterine washing was administered prior to insemination in patients diagnosed with unexplained infertility.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date June 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria:

- age of 18-44 years; presence of regular menstrual cycles and ovulation; absence of tubal occlusion on HSG; sperm concentration >15 million spermatozoa/ml and total sperm number >39 million/ml according to WHO criteria

Exclusion Criteria:

- the presence of endocrinologic disease; use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids; clinical findings suggestive of pelvic inflammatory disease; and the presence of undiagnosed uterine bleeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Pertubation
a lavage procedure of the intrauterine cavity and bilateral fallopian tubes

Locations
Country Name City State
Turkey Gazi University Hospital Ankara Cankaya

Sponsors (1)
Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pregnancy rate Pregnancy rate at 6 month-follow-up 6 months No
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