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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreTrial 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
2,005 Previous Clinical Trials
42,882,147 Total Patients Enrolled
13 Trials studying Infertility
5,959 Patients Enrolled for Infertility
Pomelo Care, Inc.UNKNOWN
Independence Blue CrossOTHER
6 Previous Clinical Trials
126,397 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still capacity to enroll individuals in this research project?
"Affirmative. According to the data hosted on clinicaltrials.gov, recruitment for this medical trial is still open; it was first listed on July 19th 2023 and modified most recently on July 25th of that year. This study seeks 140 participants from a single research centre."
Answered by AI
How many applicants are being accepted to participate in this experiment?
"Affirmative. Clinicaltrials.gov confirms that this research project, which was initially launched on July 19th 2023 is currently recruiting individuals to participate in the trial. A total of 140 participants are needed at a single location."
Answered by AI
Who else is applying?
What site did they apply to?
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
What portion of applicants met pre-screening criteria?
Met criteria
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