Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination

Study Overview
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Brief Summary
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The aim of the study to evaluate the possible effect of washing the insemination catheters before intrauterine insemination on the pregnancy outcomes. We know that washing the catheters are already washed in the case of embryo transfer for assisted reproductive techniques. Based on this knowledge, we also constituted the hypothesis which is about the impact of washing the catheter on the gametes and embryos. The pre-washing the catheter before intrauterine insemination may provide higher pregnancy results.

Official Title
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Does Pre-washing the Catheter With a Culture Medium Before Intrauterine Insemination Have an Effect on Pregnancy Rates?

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 1-year infertility at least one patent fallopian tube confirmed by hysterosalpingography (HSG) or laparoscopy ovulatory menstrual cycles suitable semen analysis according to the World Health Organization (WHO) criteria for intrauterine insemination Exclusion Criteria: bilateral tubal occlusion mild or severe endometriosis day 3 serum FSH (follicle-stimulating hormone) > 13 IU/L abnormal thyroid function tests, hyperprolactinemia total motile sperm count (TMSC) < 5 millions or severe teratospermia (<4% normal forms) following semen preparation more than 3 follicles above the size of 17mm on the day of ovulation triggering

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Washed Catheter<br>Washed catheter arm: will be washed with culture medium before insemination | Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination<br>* The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure<br>|
| Sham Comparator: Unwashed Catheter<br>Unwashed catheter arm: will not be washed with culture medium. | Procedure: Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination<br>* The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy will be defined as the presence of a heartbeat at 6th gestational weeks | 8 weeks after intrauterine insemination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intrauterine insemination, pre-washing catheter