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The Value of HBA in the Evaluation of Idiopathic Infertility

Sponsor
St. Luke's-Roosevelt Hospital Center (Other)
Overall Status
Completed
CT.gov ID
NCT01683435
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
2
Duration (Months)
17.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: HBA binding assay
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
Study Start Date :
Nov 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: hylauronin binding assay

HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

Other: HBA binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

Outcome Measures

Primary Outcome Measures

  1. In each of these groups we will assess presence of HBA bound sperm [immediate at time of preforming HBA test]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 The Continuum Reproductive Center New York New York United States 10019

Sponsors and Collaborators

  • St. Luke's-Roosevelt Hospital Center

Investigators

  • Principal Investigator: Martin Keltz, MD, Mount Sinai St. Luke's

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01683435
Other Study ID Numbers:
  • IRB 11-134
First Posted:
Sep 11, 2012
Last Update Posted:
Sep 2, 2015
Last Verified:
Aug 1, 2015
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Sep 2, 2015