Group Preconception Care for Fertility Patients

September 9, 2026 updated by: Anuja Dokras, University of Pennsylvania
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure measurement recorded by clinician in Penn EMR
Time Frame: From enrollment to 16 weeks
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
Time Frame: From enrollment to 16 weeks
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
Time Frame: From enrollment to 16 weeks
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
Time Frame: Enrollment, 4 months, 12 months
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
Time Frame: Enrollment, 4 months, 12 months
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
Time Frame: Enrollment, 4 months, 12 months
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
Time Frame: From enrollment to 12 months
Count of ovarian stimulation treatments
From enrollment to 12 months
Incidence of intrauterine inseminations
Time Frame: From enrollment to 12 months
Count of intrauterine insemination treatments
From enrollment to 12 months
Incidence of in vitro fertilizations
Time Frame: From enrollment to 12 months
Count of in vitro fertilization treatments
From enrollment to 12 months
Pregnancy rate
Time Frame: From enrollment to 12 months
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
Time Frame: From enrollment to 12 months
This includes the time until patients become pregnant during the study period in both groups.
From enrollment to 12 months
Patient experience
Time Frame: Enrollment to 16 weeks
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
Time Frame: From enrollment up to 18 months
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
Time Frame: Conception to delivery, approximately 9 months
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
Time Frame: Conception to delivery, approximately 9 months
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
Time Frame: Conception to delivery, approximately 9 months
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
Time Frame: At time of delivery
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
Time Frame: At time of delivery
In participants who become pregnant, the incidence of cesarean delivery
At time of delivery
Number of pregnant participants with a NICU admission
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
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
Time Frame: From date of conception to delivery date, approximately 9 months
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
Time Frame: From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery
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
Time Frame: Between 2 to 6 weeks after delivery
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Independence Blue Cross
Pomelo Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings