The Value of HBA in the Evaluation of Idiopathic Infertility
This study is currently recruiting participants.
Verified August 2012 by St. Luke's-Roosevelt Hospital Center
Sponsor:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01683435
First received: September 7, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
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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 Primary Completion Date: | January 2013 (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
- 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
- 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
- Tubal infertility as assessed by HSG or laparoscopy
Exclusion Criteria:
- women over 40, prior failed IVF
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683435
Locations
| United States, New York | |
| The Continuum Reproductive Center | Recruiting |
| New York, New York, United States, 10019 | |
| Contact: May-Tal Sauerbrun 508-212-9076 msauerbrun@chpnet.org | |
| Contact: Martin keltz 212 523 7751 mdkeltz@aol.com | |
| Sub-Investigator: Martin Keltz | |
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: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 19, 2013