The Value of HBA in the Evaluation of Idiopathic Infertility

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01683435
First received: September 7, 2012
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate


Condition Intervention
Infertility
Other: HBA binding assay

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • In each of these groups we will assess presence of HBA bound sperm [ Time Frame: immediate at time of preforming HBA test ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: May 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hylauronin binding assay Other: HBA binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups

    1. Abnormal Semen Analysis (sperm count <10 million/ml and /or rapid progressive motility < 50 %, WHO morphology <30%) normal HSG , normal ovarian reserve testing and ovulation testing
    2. Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH< 10, AMH>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
    3. Tubal infertility as assessed by HSG or laparoscopy

Exclusion Criteria:

  • women over 40, prior failed IVF
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683435

Locations
United States, New York
The Continuum Reproductive Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01683435     History of Changes
Other Study ID Numbers: IRB 11-134
Study First Received: September 7, 2012
Last Updated: August 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 21, 2014