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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Kansas
-
Wichita, Kansas, Förenta staterna, 67214
- University of Kansas School of Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- At least 18 years of age
Exclusion Criteria:
- Using a gestational carrier in the current cycle of IVF
Studieplan
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Intervention
Written materials, telephone based education
|
4 new written materials, 15-20 minute educational session by telephone
|
|
Övrig: Comparison
Written materials
|
2 written materials available on public website
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
questionnaire assessing knowledge, risk perception, self efficacy and preferences, interview about risk perception and decision making
Tidsram: Prior to IVF treatment cycle, 8 weeks
|
Prior to IVF treatment cycle, 8 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Adoption of healthy preconception behavior, self-efficacy for addressing IVF related obstetrical factors
Tidsram: Prior to IVF treatment cycle, 8 weeks
|
Prior to IVF treatment cycle, 8 weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Linda Frazier, MD, University of Kansas School of Medicine-Wichita
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 220060957
- 1R21HD053459-01A1 (U.S.S. NIH-anslag/kontrakt)
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Kliniska prövningar på Written materials, telephone based education
-
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