Back to resultsEffect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
Primary Purpose
Infertility, Pertubation, Insemination
Status
Completed
Phase
Phase 2
Locations
Turkey
Study Type
Interventional
Intervention
Pertubation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
Eligibility Criteria
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
Sites / Locations
- Gazi University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pertubation performed
Pertubation not performed
Arm Description
Study group had pertubation and insemination
Study group had insemination only
Outcomes
Primary Outcome Measures
Pregnancy rate
Pregnancy rate at 6 month-follow-up
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01999959
Brief Title
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Pertubation, Insemination
Keywords
Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pertubation performed
Arm Type
Experimental
Arm Description
Study group had pertubation and insemination
Arm Title
Pertubation not performed
Arm Type
No Intervention
Arm Description
Study group had insemination only
Intervention Type
Procedure
Intervention Name(s)
Pertubation
Intervention Description
a lavage procedure of the intrauterine cavity and bilateral fallopian tubes
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Pregnancy rate at 6 month-follow-up
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gazi University Hospital
City
Ankara
State/Province
Cankaya
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
24695882
Citation
Yildiz F, Bozkurt N, Erdem A, Erdem M, Oktem M, Onur Karabacak R. Effect of Pertubation on Pregnancy Rates before Intrauterine Insemination Treatment in Patients with Unexplained Infertility. Int J Fertil Steril. 2014 Apr;8(1):77-84. Epub 2014 Mar 9.
Results Reference
derived
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Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
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