Group preconception care for couples planning to conceive
Group Preconception Care for Fertility Patients
This study is testing whether group preconception care can help couples struggling with infertility make lifestyle changes that improve their chances of getting pregnant compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05924464 on ClinicalTrials.gov |
What this trial studies
This study aims to implement a group preconception care model for couples experiencing infertility, adapting successful group prenatal care strategies to enhance pregnancy and neonatal outcomes. Conducted in collaboration with Pomelo Care, a virtual maternity care program, the study will involve couples at Penn Fertility Care. Participants will be randomized to receive either group preconception care or standard care, focusing on lifestyle changes prior to conception.
Who should consider this trial
Good fit: Ideal candidates are new female patients at Penn Fertility Care who are planning to conceive and willing to participate in group care.
Not a fit: Patients who require a gestational carrier or have prior infertility treatments at other practices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pregnancy outcomes for couples facing infertility.
How similar studies have performed: While the adaptation of group prenatal care to preconception care is innovative, similar group care models have shown success in improving outcomes in prenatal settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female new patient seen at Penn Fertility Care for infertility or procreative management 2. Currently planning to conceive 3. Intending to carry pregnancy (i.e. will not need a gestational carrier), since our project aims to implement lifestyle changes prior to conception 4. Willing to be randomized to group preconception care versus usual care Exclusion Criteria: 1. Prior infertility treatment at other practice in this initial project, we aim to focus on patients with a new diagnosis of infertility to allow time for completion of the virtual program during the diagnostic phase and early treatment phase 2. Known need for gestational carrier, as above 3. Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking 4. Non-English speaking 5. Unable to complete electronic questionnaires due to lack of access to technology
Where this trial is running
Philadelphia, Pennsylvania
- Penn Reproductive Research Unit, 3701 Market Street, Suite 810 — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Anuja Dokras, MHCI, MD, PhD
- Email: adokras@pennmedicine.upenn.edu
- Phone: 2156627727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.