Group Preconception Care for Fertility Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Group Preconception Care

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Reproductive Research Unit, 3701 Market Street, Suite 810

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Group preconception care	Other: Group Preconception Care; Groups of 6-10 patients to initiate biweekly virtual group care sessions on a rolling basis, with completion of enrollment and the virtual curriculum within a year.
No Intervention: Control arm; Usual care (completion of questionnaires only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure measurement recorded by clinician in Penn EMR	Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no	From enrollment to 16 weeks
Weight measurement recorded by clinician in Penn EMR	Was a weight measurement recorded by a clinician in Penn EMR, yes/no	From enrollment to 16 weeks
Hemoglobin A1c testing results recorded in Penn EMR	Was a hemoglobin A1c test performed if medically indicated (history of diabetes, BMI>30) or felt necessary by health care provider, yes/no	From enrollment to 16 weeks
Change in Anxiety screening score	Generalized Anxiety Disorder 7 (GAD-7) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the seven items ranges from 0 to 21, with 21 indicating a worse outcome	Enrollment, 4 months, 12 months
Change in Depression screening score	Patient Health Questionnaire 9 (PHQ-9) will be administered to both groups at enrollment, 4 months, and 12 months. The total score for the nine items ranges from 0 to 27 where a high score indicates a worse outcome	Enrollment, 4 months, 12 months
Change in Fertility-related quality of life questionnaire score	Fertility Related Quality of Life (FertiQOL) Questionnaire will be administered to both groups at enrollment, 4 months, and 12 months. The 36 FertiQoL items are rated according to 5 types of response scales. The total score is 100, with higher scores indicating worse fertility-related quality of life.	Enrollment, 4 months, 12 months
Incidence of ovulation stimulations	Count of ovarian stimulation treatments	From enrollment to 12 months
Incidence of intrauterine inseminations	Count of intrauterine insemination treatments	From enrollment to 12 months
Incidence of in vitro fertilizations	Count of in vitro fertilization treatments	From enrollment to 12 months
Pregnancy rate	This includes the number of patients who become pregnant during the study period in both groups.	From enrollment to 12 months
Time to pregnancy in days	This includes the time until patients become pregnant during the study period in both groups.	From enrollment to 12 months
Patient experience	In the intervention arm only, brief questionnaires will be distributed after each virtual session to ask participants to rate their satisfaction with the session. Patients will also complete a cumulative evaluation at the conclusion of the sessions. These surveys will use a Likert scale with a higher score indicating a better experience.	Enrollment to 16 weeks
Miscarriage rate	Total number of miscarriages per participants who become pregnant in either group	From enrollment up to 18 months
Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy	This will be scored yes if any of the following are noted in the medical record: gestational hypertension (blood pressure >140/90 on 2 or more occasions at least 4 hours apart), severe preeclampsia (blood pressure >160/110 on 2 or more occasions at least 4 hours apart, or mildly elevated blood pressures with persistent headache, scotomata, platelet count <100,000/uL, liver function tests twice the upper limit of normal, or creatinine >1.1 mg/dL), HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), or eclampsia (elevated blood pressure with seizures).	Conception to delivery, approximately 9 months
Number of pregnant participants with a diagnosis of gestational diabetes	This will be scored yes if gestational diabletes is diagnosed. Gestational diabetes is diagnosed based on an abnormal 3-hour glucose tolerance test (1-hour test blood glucose >135mg/dL will be followed by a 3-hour test). Two or more abnormal values on the 3-hour test is diagnostic of gestational diabetes. Cutoffs are 95 fasting, 180 at 1 hour, 155 at 2 hours, and 140 at 3 hours.	Conception to delivery, approximately 9 months
Number of pregnant participants with occurrences with an antepartum hospitalizations	This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.	Conception to delivery, approximately 9 months
Number of pregnant participants with preterm birth	Preterm delivery is defined as delivery at less than 37 weeks gestational age.	At time of delivery
Number of pregnant participants with a cesarean delivery	In participants who become pregnant, the incidence of cesarean delivery	At time of delivery
Number of pregnant participants with a NICU admission	Infant admission to neonatal intensive care unit.	From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants	Total number of any presentation to the Perinatal Evaluation Center or emergency room during pregnancy	From date of conception to delivery date, approximately 9 months
Among those patients that become pregnant, delivery length of stay	Length of stay from birth to discharge, measured in hours	From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale	Edinburgh Postnatal Depression Scale will either be abstracted from the medical record, or if not administered clinically, will be administered by the study team. The total score for the ten items ranges from 0 to 30 with a higher score indicating a worse outcome.	Between 2 to 6 weeks after delivery

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Independence Blue Cross; Pomelo Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 26, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 852900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No