Group Preconception Care for Fertility Patients

University of Pennsylvania

Status: Active, not recruiting

Conditions: Infertility

Treatments: Other: Group Preconception Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05924464

852900

Details and patient eligibility

About

Group Preconception Care for Fertility Patients aims to translate the well-established group prenatal care model to preconception care to improve pregnancy and neonatal outcomes. In partnership with Pomelo Care (a virtual maternity care program), the investigators are conducting this study using couples at Penn Fertility Care.

Enrollment: 140 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Group preconception care

Treatment:

Other: Group Preconception Care

Control arm

No Intervention group

Description:

Usual care (completion of questionnaires only)