Unexplained InfertilityDNAFRAGNCT02235103
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.
An observational study of Unexplained Infertility, run by University Hospital, Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- Sperm Chromatin Dispersion Test
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with unexplained fertility treated with intra-uterine insemination (first cycle) and ovulation induction with clomiphene citrate.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Fertility Centre of the University Hospital
Ghent, East Flanders, 9000
About this study
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.
- Conditions
- Unexplained Infertility
- Being tested
- Sperm Chromatin Dispersion Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm Chromatin Dispersion TestOther
Also called Halosperm®
| Study group | Role | What they receive |
|---|---|---|
| Clinical Pregnancy | Patients who are clinically pregnant after first treatment cycle with intra-uterine insemination. Receives: Other: Sperm Chromatin Dispersion Test | |
| No Clinical Pregnancy | Patients who are not clinically pregnant after first treatment cycle with intra-uterine insemination. Receives: Other: Sperm Chromatin Dispersion Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Ultrasound to diagnose intra-uterine pregnancy
Measured: 2 1/2 weeks after insemination
Secondary outcomes (2)
Ongoing pregnancy rate
Ultrasound to diagnose an evolutive pregnancy.
Measured: 20 weeks after insemination
Live birth rate
Clinical report of the delivery by the obstetrician
Measured: 42 weeks after insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Vandekerckhove, MD, Principal investigator, Fertility Centre, University Hospital Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235103
- Sponsor's protocol ID
- B670201316616
- Acronym
- DNAFRAG
- Status last verified
- Mar 2016
- First submitted
- 5 Sep 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02235103
- Acronym / sponsor ID
- DNAFRAG / B670201316616
- Conditions
- Unexplained Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Pregnancy | – | Other: Sperm Chromatin Dispersion TestPatients who are clinically pregnant after first treatment cycle with intra-uterine insemination. |
| No Clinical Pregnancy | – | Other: Sperm Chromatin Dispersion TestPatients who are not clinically pregnant after first treatment cycle with intra-uterine insemination. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with unexplained fertility treated with intra-uterine insemination (first cycle) and ovulation induction with clomiphene citrate.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm Chromatin Dispersion TestAlso: Halosperm® | Other | Clinical Pregnancy, No Clinical Pregnancy |
Primary outcome
Clinical pregnancy rate
Time frame: 2 1/2 weeks after insemination
Ultrasound to diagnose intra-uterine pregnancy
2 secondary outcomes
Ongoing pregnancy rate
Time frame: 20 weeks after insemination
Live birth rate
Time frame: 42 weeks after insemination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Vandekerckhove, MD principal investigator
Fertility Centre, University Hospital Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unexplained Infertility, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 2 1/2 weeks after insemination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.