Anonymous DonorsNCT01219374
Study of Ovum Donors After Donation
An observational study of Anonymous Donors, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anonymous Donors
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Anonymous egg donors
All anonymous egg donors are eligible for participation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, 07690
About this study
Official title: A Longitudinal Prospective Study of Ovum Donors After Donation
To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories.
Read the 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.
- Conditions
- Anonymous Donors
- Keywords
- egg donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| egg donors | anonymous egg donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Do recipients' attitudes and reactions change over time regarding the selection criteria for their donors?
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
Measured: 12-15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anonymous DonorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea M Braverman, PhD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219374
- Sponsor's protocol ID
- RMA-00-08
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Prospective Study of Ovum Donors After Donation
- ClinicalTrials.gov ID
- NCT01219374
- Acronym / sponsor ID
- RMA-00-08
- Conditions
- Anonymous Donors
- Keywords
- egg donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the attitudes and reactions of ovum donors prospectively after ovum donation and to follow their medical histories.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| egg donors | – | –anonymous egg donors |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Anonymous egg donors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Do recipients' attitudes and reactions change over time regarding the selection criteria for their donors?
Time frame: 12-15 Months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea M Braverman, PhD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anonymous Donors, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Do recipients' attitudes and reactions change over time regarding the selection criteria for their donors? (time frame: 12-15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.