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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Kansas
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Wichita, Kansas, Stati Uniti, 67214
- University of Kansas School of Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- Using a gestational carrier in the current cycle of IVF
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Altro: Comparison
Written materials
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2 written materials available on public website
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Lasso di tempo: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Lasso di tempo: Prior to IVF treatment cycle, 8 weeks
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Prior to IVF treatment cycle, 8 weeks
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Linda Frazier, MD, University of Kansas School of Medicine-Wichita
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 220060957
- 1R21HD053459-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
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