Skip to content

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.

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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02235103
Acronym
DNAFRAG
Enrollment
21
Registered
2014-09-09
Start date
2014-04-30
Completion date
2016-03-31
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Infertility

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.

Interventions

OTHERSperm Chromatin Dispersion Test

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical pregnancy rate2 1/2 weeks after inseminationUltrasound to diagnose intra-uterine pregnancy

Secondary

MeasureTime frameDescription
Ongoing pregnancy rate20 weeks after inseminationUltrasound to diagnose an evolutive pregnancy.
Live birth rate42 weeks after inseminationClinical report of the delivery by the obstetrician

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026