PregnancyNCT00341822
Invasive Prenatal Testing Decisions in Pregnancy After Infertility
An observational study of Pregnancy, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test (IPT) procedure, such as amniocentesis or chorionic villus sampling. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Pregnancy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2006to 28 Dec 2007
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women.
- Self-reported history of infertility.
- Currently pregnant.
- First pregnancy after period of infertility.
- Have been offered IPT during current pregnancy for risk of aneuploidy due to maternal age greater than 35 years, abnormal first or second trimester screening or an ultrasound anomaly.
- Have made decision about IPT.
- Ability to read and write English.
Who cannot join
- Men, children.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prenatal Testing Decisions in Pregnancy After Infertility
This study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test (IPT) procedure, such as amniocentesis or chorionic villus sampling. Women who become pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have IPT they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precarious.
Women who are pregnant with their first child after a period of infertility and have made a decision regarding whether or not to undergo IPT may be eligible for this study.
Read more
Participants complete an online password-protected questionnaire that measures infertility and decision-making variables and explores women's perceptions of the impact of infertility on their IPT decision-making process. The questionnaire covers the following areas:
- Subject's demographic information, such as age, marital status, number of children, education, race, ethnicity
- Subject's infertility history
- Subject's thoughts and feelings about infertility
- Subject's thoughts and concerns about other people's (e.g., husband, doctor, other infertile women) opinions about IPT
- Subject's decision about whether or not to have IPT and her feelings regarding the decision
- The effect of subject's infertility history on her decision to have or not have IPT
Read the detailed description
Women who are pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have invasive prenatal testing they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precious. The proposed study aims to explore the invasive prenatal testing decision-making experiences of women who are pregnant after infertility. A cross-sectional design will be used to investigate relationships between the infertility experience and decisional conflict associated with deciding whether or not to have invasive prenatal testing. Women who are pregnant after infertility will be recruited from online support groups and websites for pregnancy after infertility. Participants will be asked to complete a questionnaire that measures infertility and decision-making variables and elicits their perceptions of the impact of infertility on their IPT decision-making experience. The main outcome measure is decisional conflict.
- Conditions
- Pregnancy
- Keywords
- Amniocentesis, Chorionic Villus Sampling, Fertility, Genetic Counseling, Decisional Conflict, Prenatal Testing, Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start29 Mar 2006
- Study completion28 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341822
- Sponsor's protocol ID
- 999906132
- Other IDs
- 06-HG-N132
- Status last verified
- 28 Dec 2007
- First submitted
- 19 Jun 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Reading AE, Chang LC, Kerin JF. Attitudes and anxiety levels in women conceiving through in vitro fertilization and gamete intrafallopian transfer. Fertil Steril. 1989 Jul;52(1):95-9. doi: 10.1016/s0015-0282(16)60796-3.
PubMed 2663553
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Testing Decisions in Pregnancy After Infertility
- ClinicalTrials.gov ID
- NCT00341822
- Acronym / sponsor ID
- 999906132
- Conditions
- Pregnancy
- Keywords
- Amniocentesis, Chorionic Villus Sampling, Fertility, Genetic Counseling, Decisional Conflict, Prenatal Testing, Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 29 Mar 2006
- Study completion
- 28 Dec 2007
- First posted
- 21 Jun 2006 (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.
This study will explore the decision-making experiences of women who are currently pregnant following a period of infertility on whether or not to undergo an invasive prenatal test (IPT) procedure, such as amniocentesis or chorionic villus sampling. Women who become pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have IPT they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precarious.
Women who are pregnant with their first child after a period of infertility and have made a decision regarding whether or not to undergo IPT may be eligible for this study.
Participants complete an online password-protected questionnaire that measures infertility and decision-making variables and explores women's perceptions of the impact of infertility on their IPT decision-making process. The questionnaire covers the following areas:
- Subject's demographic information, such as age, marital status, number of children, education, race, ethnicity
- Subject's infertility history
- Subject's thoughts and feelings about infertility
- Subject's thoughts and concerns about other people's (e.g., husband, doctor, other infertile women) opinions about IPT
- Subject's decision about whether or not to have IPT and her feelings regarding the decision
- The effect of subject's infertility history on her decision to have or not have IPT
Detailed description
Women who are pregnant after infertility often experience heightened anxiety regarding the outcome of the pregnancy. When choosing whether or not to have invasive prenatal testing they are faced with a complex decision, set in the unique context of a pregnancy that they often perceive as exceptionally precious. The proposed study aims to explore the invasive prenatal testing decision-making experiences of women who are pregnant after infertility. A cross-sectional design will be used to investigate relationships between the infertility experience and decisional conflict associated with deciding whether or not to have invasive prenatal testing. Women who are pregnant after infertility will be recruited from online support groups and websites for pregnancy after infertility. Participants will be asked to complete a questionnaire that measures infertility and decision-making variables and elicits their perceptions of the impact of infertility on their IPT decision-making experience. The main outcome measure is decisional conflict.
Study design
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women.
- Self-reported history of infertility.
- Currently pregnant.
- First pregnancy after period of infertility.
- Have been offered IPT during current pregnancy for risk of aneuploidy due to maternal age greater than 35 years, abnormal first or second trimester screening or an ultrasound anomaly.
Key exclusion criteria (1 listed)
- Men, children.
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
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 2663553Reading AE, Chang LC, Kerin JF. Attitudes and anxiety levels in women conceiving through in vitro fertilization and gamete intrafallopian transfer. Fertil Steril. 1989 Jul;52(1):95-9. doi: 10.1016/s0015-0282(16)60796-3.
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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 Pregnancy, run by National Human Genome Research Institute (NHGRI) 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 7 inclusion and 1 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341822, which also lists 1 linked publication.
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 2 Jul 2017.