Communication With in Vitro Fertilization (IVF) Patients About Risks
Improving Communication With IVF Patients About Risks Such as Multiple Births
The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant.
Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
The long-term objective of this research is to improve patient understanding of the known and strongly suspected risks from treating infertility with assisted reproductive technologies such as in vitro fertilization (IVF). During IVF, when more embryos are transferred to the uterus, the risk of pregnancy with multiple fetuses increases. In addition, single infants conceived with IVF are at greater risk for low birth weight. This study will promote behaviors that may reduce these risks. One in 3 women who completes a pregnancy conceived with assisted reproductive technologies such as IVF delivers multiples, and these treatments produce over 12,000 multiple birth deliveries annually in the United States. This study will lead to a better understanding of the most effective ways to counsel IVF patients about the embryo transfer decision. This study will also help define how to prepare IVF patients to work most effectively with their prenatal care team to manage IVF-related obstetrical risks.
Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Kansas
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Wichita, Kansas, Vereinigte Staaten, 67214
- University of Kansas School of Medicine
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- Using a gestational carrier in the current cycle of IVF
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Intervention
Written materials, telephone based education
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4 new written materials, 15-20 minute educational session by telephone
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Sonstiges: Comparison
Written materials
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2 written materials available on public website
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Zeitfenster: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Zeitfenster: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Linda Frazier, MD, University of Kansas School of Medicine-Wichita
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 220060957
- 1R21HD053459-01A1 (US NIH Stipendium/Vertrag)
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