Family ResearchNCT03966352
Pathways to Fatherhood
An observational study of Family Research, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Family Research
- What is being tested?
- Questionnaire
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2019to 31 Dec 2019
- 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 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Gay men who sought or are currently seeking family building services at an infertility practice through third party reproduction
Who may be able to join
- Men over age 18 who self-identify as gay
- Participants should be individuals who are seeking or have sought reproductive services at RMA New Jersey locations.
- Participants may be included if they have not yet gone through the assisted reproductive process but are considering fatherhood and identify as gay.
Who cannot join
- Individuals who are not 18 years of age or older.
- Participants who do not self-identify as gay males.
- Female patients.
- Failure of the participant to agree to enrollment in the study with written consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Family Building Decisions for Gay Men
The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children.
Read the detailed description
The purpose of this study is to better understand treatment considerations, obstacles, motivations, and outcomes for gay men through a survey based questionnaire study.
- Conditions
- Family Research
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Enrolled subjects will complete a questionnaire to ascertain information on treatment considerations, obstacles, motivations, and outcomes encountered on their pathway to fatherhood.
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to survey questions
assess response to questions regarding quality of life, general health, demographic info as well as vies on sperm, egg donation, gestational carriers, legal and financial issues as well as adoption or foster care
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start24 May 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ResearchStudies 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
- Family based
- Time perspective
- Other
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03966352
- Sponsor's protocol ID
- RMA-2019-04
- Status last verified
- Mar 2020
- First submitted
- 24 May 2019
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Building Decisions for Gay Men
- ClinicalTrials.gov ID
- NCT03966352
- Acronym / sponsor ID
- RMA-2019-04
- Conditions
- Family Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 24 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 May 2019 (actual)
- 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.
The purpose of this study is to better understand the decision-making process that gay couples go through in order to have children.
Detailed description
The purpose of this study is to better understand treatment considerations, obstacles, motivations, and outcomes for gay men through a survey based questionnaire study.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gay men who sought or are currently seeking family building services at an infertility practice through third party reproduction
Key inclusion criteria (3 listed)
- Men over age 18 who self-identify as gay
- Participants should be individuals who are seeking or have sought reproductive services at RMA New Jersey locations.
- Participants may be included if they have not yet gone through the assisted reproductive process but are considering fatherhood and identify as gay.
Key exclusion criteria (4 listed)
- Individuals who are not 18 years of age or older.
- Participants who do not self-identify as gay males.
- Female patients.
- Failure of the participant to agree to enrollment in the study with written consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireEnrolled subjects will complete a questionnaire to ascertain information on treatment considerations, obstacles, motivations, and outcomes encountered on their pathway to fatherhood. | Other | – |
Primary outcome
Response to survey questions
Time frame: 1 week
assess response to questions regarding quality of life, general health, demographic info as well as vies on sperm, egg donation, gestational carriers, legal and financial issues as well as adoption or foster care
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 9 Mar 2020.
- Individual participant dataSharing planned: No
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Family Research
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Family Research, 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?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 9 Mar 2020. 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?
Response to survey questions (time frame: 1 week). 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 9 Mar 2020.