NCT00341822

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 28, 2007

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

AmniocentesisChorionic Villus SamplingFertilityGenetic CounselingDecisional ConflictPrenatal TestingQuestionnaire

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Men, children.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 2663553BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

March 29, 2006

Study Completion

December 28, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-28

Locations