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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment, 4 months, 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment, 4 months, 12 months
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 moreAwards & 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
2,084 Previous Clinical Trials
42,726,908 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I plan to become pregnant myself without using a surrogate.I am willing to be assigned to a specific care group before pregnancy.I am a new female patient at Penn Fertility Care for infertility or help with getting pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention arm
- Group 2: Control arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.