The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.

Study Overview
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Brief Summary
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Recent research has revealed that subtle abnormalities can be found in sperm samples that seem to be normal with conventional analysis techniques. The DNA in the sperm heads is sometimes fragmented and this may be the reason why couples with a diagnosis of unexplained infertility do not achieve pregnancy. We are planning a study to examine the incidence of DNA fragmentation in the sperm of couples with previously unexplained infertility. In a first treatment cycle with intra-uterine insemination the percentage of DNA fragmentation in sperm will be measured. Afterwards the results of the patients who are pregnant will be compared with those of the not pregnant ones. We expect to find differences between both groups. 100 patients will be included in the study.

Official Title
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The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.

Conditions
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Unexplained Infertility

Intervention / Treatment
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* Other: Sperm Chromatin Dispersion Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes; normal sperm analysis (WHO criteria). Patient agrees to have a first treatment cycle with intra-uterine insemination and ovulation-induction with clomiphene citrate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clinical Pregnancy<br>Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination. | Other: Sperm Chromatin Dispersion Test<br> <br> * Other names: Halosperm®;|
| No Clinical Pregnancy<br>Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination. | Other: Sperm Chromatin Dispersion Test<br> <br> * Other names: Halosperm®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Ultrasound to diagnose intra-uterine pregnancy | 2 1/2 weeks after insemination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Ultrasound to diagnose an evolutive pregnancy. | 20 weeks after insemination | 
| Live birth rate | Clinical report of the delivery by the obstetrician | 42 weeks after insemination |