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Behavioural Intervention

Group Preconception Care for Infertility

N/A
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment, 4 months, 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is researching if a group care model can improve pregnancy and newborn outcomes for couples trying to conceive. #fertility #preconceptioncare

Who is the study for?
This trial is for women who are new patients at Penn Fertility Care, currently trying to conceive and planning to carry a pregnancy themselves. They should be willing to try group preconception care or usual care and able to use technology for questionnaires. It's not open to those who've had prior infertility treatments elsewhere, need a gestational carrier, require genetic testing on embryos, or can't complete surveys in English.
What is being tested?
The study tests Group Preconception Care designed to improve pregnancy outcomes by implementing lifestyle changes before conception. Participants will either receive this group care through Pomelo Care's virtual program or stick with the standard individual care approach.
What are the potential side effects?
Since the intervention involves lifestyle changes rather than medication, traditional side effects are not expected. However, participants may experience stress or emotional impacts from group dynamics and discussions about fertility.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 4 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment, 4 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Among those patients that become pregnant, delivery length of stay
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale
Blood pressure measurement recorded by clinician in Penn EMR
+19 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Group preconception care
Group II: Control armActive Control1 Intervention
Usual care (completion of questionnaires only)

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,075 Previous Clinical Trials
42,719,706 Total Patients Enrolled
13 Trials studying Infertility
5,964 Patients Enrolled for Infertility
Pomelo Care, Inc.UNKNOWN
Independence Blue CrossOTHER
6 Previous Clinical Trials
126,224 Total Patients Enrolled

Media Library

Group Preconception Care (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05924464 — N/A
Infertility Research Study Groups: Intervention arm, Control arm
Infertility Clinical Trial 2023: Group Preconception Care Highlights & Side Effects. Trial Name: NCT05924464 — N/A
Group Preconception Care (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924464 — N/A
~38 spots leftby May 2025
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