Back to resultsGroup Preconception Care for Fertility Patients
Primary Purpose
Infertility
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Preconception Care
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Penn Reproductive Research Unit, 3701 Market Street, Suite 810Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
Group preconception care
Usual care (completion of questionnaires only)
Outcomes
Primary Outcome Measures
Blood pressure measurement recorded by clinician in Penn EMR
Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Weight measurement recorded by clinician in Penn EMR
Was a weight measurement recorded by a clinician in Penn EMR, yes/no
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
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
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
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.
Incidence of ovulation stimulations
Count of ovarian stimulation treatments
Incidence of intrauterine inseminations
Count of intrauterine insemination treatments
Incidence of in vitro fertilizations
Count of in vitro fertilization treatments
Pregnancy rate
This includes the number of patients who become pregnant during the study period in both groups.
Time to pregnancy in days
This includes the time until patients become pregnant during the study period in both groups.
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.
Miscarriage rate
Total number of miscarriages per participants who become pregnant in either group
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).
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.
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.
Number of pregnant participants with preterm birth
Preterm delivery is defined as delivery at less than 37 weeks gestational age.
Number of pregnant participants with a cesarean delivery
In participants who become pregnant, the incidence of cesarean delivery
Number of pregnant participants with a NICU admission
Infant admission to neonatal intensive care unit.
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
Among those patients that become pregnant, delivery length of stay
Length of stay from birth to discharge, measured in hours
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05924464
First Posted
May 26, 2023
Last Updated
July 25, 2023
Sponsor
University of Pennsylvania
Collaborators
Pomelo Care, Inc., Independence Blue Cross
1. Study Identification
Unique Protocol Identification Number
NCT05924464
Brief Title
Group Preconception Care for Fertility Patients
Official Title
Group Preconception Care for Fertility Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Pomelo Care, Inc., Independence Blue Cross
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Group preconception care
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Usual care (completion of questionnaires only)
Intervention Type
Other
Intervention Name(s)
Group Preconception Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood pressure measurement recorded by clinician in Penn EMR
Description
Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Time Frame
From enrollment to 16 weeks
Title
Weight measurement recorded by clinician in Penn EMR
Description
Was a weight measurement recorded by a clinician in Penn EMR, yes/no
Time Frame
From enrollment to 16 weeks
Title
Hemoglobin A1c testing results recorded in Penn EMR
Description
Was a hemoglobin A1c test performed if medically indicated (history of diabetes, BMI>30) or felt necessary by health care provider, yes/no
Time Frame
From enrollment to 16 weeks
Title
Change in Anxiety screening score
Description
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
Time Frame
Enrollment, 4 months, 12 months
Title
Change in Depression screening score
Description
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
Time Frame
Enrollment, 4 months, 12 months
Title
Change in Fertility-related quality of life questionnaire score
Description
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.
Time Frame
Enrollment, 4 months, 12 months
Title
Incidence of ovulation stimulations
Description
Count of ovarian stimulation treatments
Time Frame
From enrollment to 12 months
Title
Incidence of intrauterine inseminations
Description
Count of intrauterine insemination treatments
Time Frame
From enrollment to 12 months
Title
Incidence of in vitro fertilizations
Description
Count of in vitro fertilization treatments
Time Frame
From enrollment to 12 months
Title
Pregnancy rate
Description
This includes the number of patients who become pregnant during the study period in both groups.
Time Frame
From enrollment to 12 months
Title
Time to pregnancy in days
Description
This includes the time until patients become pregnant during the study period in both groups.
Time Frame
From enrollment to 12 months
Title
Patient experience
Description
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.
Time Frame
Enrollment to 16 weeks
Title
Miscarriage rate
Description
Total number of miscarriages per participants who become pregnant in either group
Time Frame
From enrollment up to 18 months
Title
Number of pregnant participants with occurrence of a hypertensive disorder of pregnancy
Description
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).
Time Frame
Conception to delivery, approximately 9 months
Title
Number of pregnant participants with a diagnosis of gestational diabetes
Description
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.
Time Frame
Conception to delivery, approximately 9 months
Title
Number of pregnant participants with occurrences with an antepartum hospitalizations
Description
This includes hospital admissions during the pregnancy for any pregnancy or non-pregnancy related complications.
Time Frame
Conception to delivery, approximately 9 months
Title
Number of pregnant participants with preterm birth
Description
Preterm delivery is defined as delivery at less than 37 weeks gestational age.
Time Frame
At time of delivery
Title
Number of pregnant participants with a cesarean delivery
Description
In participants who become pregnant, the incidence of cesarean delivery
Time Frame
At time of delivery
Title
Number of pregnant participants with a NICU admission
Description
Infant admission to neonatal intensive care unit.
Time Frame
From date of delivery to date of discharge from hospital postpartum, up to 6 weeks from delivery
Title
Number of PEC (Perinatal Evaluation Center)/emergency room visits in pregnant participants
Description
Total number of any presentation to the Perinatal Evaluation Center or emergency room during pregnancy
Time Frame
From date of conception to delivery date, approximately 9 months
Title
Among those patients that become pregnant, delivery length of stay
Description
Length of stay from birth to discharge, measured in hours
Time Frame
From date of delivery to date of discharge from hospital postpartum, up to six weeks from delivery
Title
Among those patients that become pregnant, score on the Edinburgh Postnatal Depression Scale
Description
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.
Time Frame
Between 2 to 6 weeks after delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anuja Dokras, MHCI, MD, PhD
Phone
2156627727
Email
adokras@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Lee, MD
Phone
2156627727
Email
leeir@pennmedicine.upenn.edu
Facility Information:
Facility Name
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iris Lee, MD
Phone
215-662-7727
Email
iris.lee@pennmedicin.upenn.edu
First Name & Middle Initial & Last Name & Degree
Anuja Dokras, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Group Preconception Care for Fertility Patients
We'll reach out to this number within 24 hrs