InfertilityNCT05924464
Group Preconception Care for Fertility Patients
A study testing Group Preconception Care in people with Infertility, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Group Preconception Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia, Pennsylvania, 19104
About this study
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
- Being tested
- Group Preconception Care
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Preconception CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Group preconception care Receives: Other: Group Preconception Care |
| Control arm | No intervention | Usual care (completion of questionnaires only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement recorded by clinician in Penn EMR
Was a blood pressure measurement recorded by a clinician in Penn EMR, yes/no
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Enrollment, 4 months, 12 months
Incidence of ovulation stimulations
Count of ovarian stimulation treatments
Measured: From enrollment to 12 months
Incidence of intrauterine inseminations
Count of intrauterine insemination treatments
Measured: From enrollment to 12 months
Incidence of in vitro fertilizations
Count of in vitro fertilization treatments
Measured: From enrollment to 12 months
Pregnancy rate
This includes the number of patients who become pregnant during the study period in both groups.
Measured: 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.
Measured: 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.
Measured: Enrollment to 16 weeks
Miscarriage rate
Total number of miscarriages per participants who become pregnant in either group
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At time of delivery
Number of pregnant participants with a cesarean delivery
In participants who become pregnant, the incidence of cesarean delivery
Measured: At time of delivery
Number of pregnant participants with a NICU admission
Infant admission to neonatal intensive care unit.
Measured: 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
Measured: 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
Measured: 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.
Measured: Between 2 to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start19 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pomelo Care, Inc., Independence Blue Cross
- Responsible party
- Principal investigator, Anuja Dokras, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924464
- Sponsor's protocol ID
- 852900
- Status last verified
- Sep 2026
- First submitted
- 26 May 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Preconception Care for Fertility Patients
- ClinicalTrials.gov ID
- NCT05924464
- Acronym / sponsor ID
- 852900
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pomelo Care, Inc., Independence Blue Cross
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Group Preconception CareGroup preconception care |
| Control arm | No intervention | –Usual care (completion of questionnaires only) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Preconception CareGroups 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. | Other | Intervention arm |
Primary outcome
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
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
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
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
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
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.
Incidence of ovulation stimulations
Time frame: From enrollment to 12 months
Count of ovarian stimulation treatments
Incidence of intrauterine inseminations
Time frame: From enrollment to 12 months
Count of intrauterine insemination treatments
Incidence of in vitro fertilizations
Time frame: From enrollment to 12 months
Count of in vitro fertilization treatments
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.
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.
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.
Miscarriage rate
Time frame: From enrollment up to 18 months
Total number of miscarriages per participants who become pregnant in either group
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).
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.
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.
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.
Number of pregnant participants with a cesarean delivery
Time frame: At time of delivery
In participants who become pregnant, the incidence of cesarean 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.
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Preconception Care in people with Infertility, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement recorded by clinician in Penn EMR (time frame: From enrollment to 16 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.