Study of Ovum Donors After Donation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier:
NCT01219374
First received: October 8, 2010
Last updated: January 22, 2013
Last verified: January 2013
  Purpose

To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories.


Condition
Anonymous Donors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Longitudinal Prospective Study of Ovum Donors After Donation

Further study details as provided by Reproductive Medicine Associates of New Jersey:

Primary Outcome Measures:
  • Do recipients' attitudes and reactions change over time regarding the selection criteria for their donors? [ Time Frame: 12-15 Months ] [ Designated as safety issue: No ]
    Analysis of recipients' attitudes and reactions at initial psychoeducational consultation, a week after the initial psychoeducational consultion, at donor match and 3 months after delivery


Enrollment: 500
Study Start Date: December 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
egg donors
anonymous egg donors

Detailed Description:

Although several studies have explored donor's reactions and experiences up to a year post donation, no study has explored how donor attitudes and reactions change over time. Currently, there is no long-term data available to describe donor's feelings and reactions to their donation. Consequently, programs have no guidance to counsel prospective donors about whether donors' attitudes change towards their own participation, contact with any offspring, or concerns about the donation. In addition, just as ovum donors' initial health histories were shared anonymously with the recipient(s), any updated information gathered in this study would be shared anonymously with the recipient(s) or offspring should they request those updates.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Anonymous egg donors

Criteria

All anonymous egg donors are eligible for participation.

  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: NCT01219374

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, United States, 07690
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Andrea M Braverman, PhD Reproductive Medicine Associates of New Jersey
  More Information

Additional Information:
No publications provided

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT01219374     History of Changes
Other Study ID Numbers: RMA-00-08
Study First Received: October 8, 2010
Last Updated: January 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Medicine Associates of New Jersey:
egg donor

ClinicalTrials.gov processed this record on August 01, 2014