Group Preconception Care for Fertility Patients

NCT05924464 | Active Not Recruiting

• 1 other identifier: 852900
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (22)

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

Group preconception care

Other: Group Preconception Care

Control arm

NO INTERVENTION

Usual care (completion of questionnaires only)

Interventions

Group Preconception Care OTHER

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.

Intervention arm

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female new patient seen at Penn Fertility Care for infertility or procreative management
• Currently planning to conceive
• Intending to carry pregnancy (i.e. will not need a gestational carrier), since our project aims to implement lifestyle changes prior to conception
• Willing to be randomized to group preconception care versus usual care

You may not qualify if:

• 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
• Known need for gestational carrier, as above
• Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking
• Non-English speaking
• Unable to complete electronic questionnaires due to lack of access to technology

Sponsors & Collaborators

• University of Pennsylvania: lead
• Pomelo Care, Inc.: collaborator
• Independence Blue Cross: collaborator

Study Sites (1)

Penn Reproductive Research Unit, 3701 Market Street, Suite 810

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Penn PCOS Center

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 29, 2023
• Study Start: July 19, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

US (1)