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.

Completed

• Conditions: Unexplained Infertility
• Interventions: Other: Sperm Chromatin Dispersion Test

• Registration Number: NCT02235103
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-09
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical Pregnancy	Sperm Chromatin Dispersion Test	Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination.
No Clinical Pregnancy	Sperm Chromatin Dispersion Test	Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	2 1/2 weeks after insemination	Ultrasound to diagnose intra-uterine pregnancy

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	20 weeks after insemination	Ultrasound to diagnose an evolutive pregnancy.
Live birth rate	42 weeks after insemination	Clinical report of the delivery by the obstetrician

Trial Locations

Locations (1)

Fertility Centre of the University Hospital; 🇧🇪 Ghent, East Flanders, Belgium