DNAFRAG: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clinical Pregnancy Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination. |
Other: Sperm Chromatin Dispersion Test
Other Names:
|
| No Clinical Pregnancy Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination. |
Other: Sperm Chromatin Dispersion Test
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Clinical pregnancy rate [2 1/2 weeks after insemination]
Ultrasound to diagnose intra-uterine pregnancy
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fertility Centre of the University Hospital | Ghent | East Flanders | Belgium | 9000 |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Frank Vandekerckhove, MD, Fertility Centre, University Hospital Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B670201316616