The Predictive Value of the Sperm Chromatin Dispersion Te... | NCT02235103

Studies
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.

NCT02235103

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Mar 14, 2016Estimated

Enrollment

21Actual

Phase

Not provided

Conditions

Unexplained Infertility

Interventions

Sperm Chromatin Dispersion Test

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief 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.

Official Title

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Sep 5, 2014

First Submission Date that Met QC Criteria

Sep 5, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2016

Last Update Posted Date

Mar 14, 2016Estimated

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sperm Chromatin Dispersion Test	Other		Clinical Pregnancy No Clinical Pregnancy	Halosperm®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Patients with unexplained fertility treated with intra-uterine insemination (first cycle) and ovulation induction with clomiphene citrate.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frank Vandekerckhove, MD	Fertility Centre, University Hospital Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility Centre of the University Hospital		Ghent	East Flanders	9000	Belgium

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.