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 | Completed

• 1 other identifier: B670201316616
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Ultrasound to diagnose intra-uterine pregnancy

  2 1/2 weeks after insemination

Secondary Outcomes (2)

• Ongoing pregnancy rate

  20 weeks after insemination

• Live birth rate

  42 weeks after insemination

Study Arms (2)

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

Sperm Chromatin Dispersion Test OTHER

Also known as: Halosperm®

Clinical Pregnancy; No Clinical Pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Fertility Centre of the University Hospital

Ghent, East Flanders, 9000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sperm samples

Study Officials

• Frank Vandekerckhove, MD

  Fertility Centre, University Hospital Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: April 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

BE (1)