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Completed

NCT Number: NCT00341822

Invasive 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.

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

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Key information

Conditions

Age range

35 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

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.

Exclusion criteria

Men, children.

Sponsors and collaborators

Lead sponsor

National Human Genome Research Institute (NHGRI)

Nih

Registry information

Official study title

Prenatal Testing Decisions in Pregnancy After Infertility

Important dates

Study start
2006
Study completion
2007
First posted
Jun 21, 2006
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.