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.

Unexplained Infertility Clinical Trial

— DNAFRAG  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235103
• Other study ID #: B670201316616
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: March 11, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

Other:
• Sperm Chromatin Dispersion Test

Locations

Country	Name	City	State
Belgium	Fertility Centre of the University Hospital	Ghent	East Flanders

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Ultrasound to diagnose intra-uterine pregnancy	2 1/2 weeks after insemination	No
Secondary	Ongoing pregnancy rate	Ultrasound to diagnose an evolutive pregnancy.	20 weeks after insemination	No
Secondary	Live birth rate	Clinical report of the delivery by the obstetrician	42 weeks after insemination	No