Group Preconception Care for Infertility

Overseen By Anuja Dokras, MD, PhD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Prior infertility treatment, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to improving pregnancy outcomes for individuals experiencing infertility. It focuses on group preconception care, which involves preparing for pregnancy in a supportive group setting. The trial compares this group care with usual individual care to determine which method is more effective. Ideal participants are new female patients at Penn Fertility Care who plan to conceive and are interested in trying a group care approach. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could enhance fertility care options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Group Preconception Care is safe for fertility patients?

Research has shown that group preconception care is based on a well-known method used during pregnancy. This type of care has improved health outcomes for both mothers and babies. Although limited safety data exists specifically for group preconception care, patients have well-received similar prenatal care models.

Preconception care generally aims to enhance overall health before pregnancy, often including vaccinations, health screenings, and other preventive steps. This approach is considered safe because it focuses on health improvement rather than medications or invasive procedures.

In summary, group preconception care is designed as a supportive and safe way to help couples prepare for pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about group preconception care for infertility because it offers a holistic approach that differs from traditional treatments like medication and assisted reproductive technologies. Unlike standard options, which often focus on addressing physical aspects through drugs or procedures, this method emphasizes comprehensive support, including lifestyle changes, education, and emotional well-being in a group setting. By fostering a supportive community and addressing multiple aspects of health before conception, this approach has the potential to enhance overall fertility outcomes and reduce stress for individuals trying to conceive.

What evidence suggests that Group Preconception Care is effective for improving fertility outcomes?

Studies have shown that preconception care, which involves taking care of health before pregnancy, can positively affect both pregnancy and newborn health. Research indicates that these health steps help women learn more, adopt healthier attitudes, and make better lifestyle choices, all crucial for a healthy pregnancy. Preconception care is linked to better mental health and improvements in key health measures like blood pressure and weight, which are important for conception. This trial will evaluate the group preconception care model, based on the successful group prenatal care model. Although limited data exists on this specific approach, it has effectively improved outcomes by offering support and education in a group setting. Participants in the intervention arm will receive group preconception care, while those in the control arm will receive usual care, which involves completing questionnaires only. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for women who are new patients at Penn Fertility Care, currently trying to conceive and planning to carry a pregnancy themselves. They should be willing to try group preconception care or usual care and able to use technology for questionnaires. It's not open to those who've had prior infertility treatments elsewhere, need a gestational carrier, require genetic testing on embryos, or can't complete surveys in English.

Inclusion Criteria

Currently planning to conceive

I am a new female patient at Penn Fertility Care for infertility or help with getting pregnant.

I plan to become pregnant myself without using a surrogate.

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

Planning preimplantation genetic testing for monogenic disorders or egg/embryo banking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconception Care

Participants receive group preconception care to improve pregnancy and neonatal outcomes

16 weeks

Virtual sessions with Pomelo Care

Pregnancy Monitoring

Participants are monitored from conception to delivery for various health outcomes

Approximately 9 months

Follow-up

Participants are monitored for safety and effectiveness after delivery

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Group Preconception Care

Trial Overview The study tests Group Preconception Care designed to improve pregnancy outcomes by implementing lifestyle changes before conception. Participants will either receive this group care through Pomelo Care's virtual program or stick with the standard individual care approach.

How Is the Trial Designed?

Group I: Intervention arm Experimental Treatment 1 Intervention

Group preconception care

Group II: Control arm Active Control 1 Intervention

Usual care (completion of questionnaires only)

Group Preconception Care is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Preconception Care for:

• General health optimization before pregnancy
• Risk factor assessment for pregnancy complications

Approved in European Union as Preconception Care for:

• Pre-pregnancy health assessment
• Education on healthy lifestyle choices for reproductive health

Approved in Canada as Preconception Care for:

• Pre-pregnancy counseling
• Risk factor management for pregnancy

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Pomelo Care, Inc.

Collaborator

Trials

1

Recruited

140+

Independence Blue Cross

Collaborator

Trials

7

Recruited

126,000+

Published Research Related to This Trial

Israeli gynecologists showed significantly lower engagement in preconception counseling (mean score of 11.3) compared to prenatal care (mean score of 16.9), indicating a gap in preventive care for women of reproductive age.

While most gynecologists recommended folic acid and genetic screening during the first prenatal visit (99% and 94% respectively), only 42% and 62% provided similar recommendations for women not yet pregnant, highlighting a need for improved awareness and guidelines for preconception care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception care--when and what: the attitude of Israeli gynaecologists to preconception counseling. Riskin-Mashiah, S., Auslander, R.[2022]

Preconception counseling is crucial for reproductive-aged women, as it helps healthcare providers assess individual pregnancy wishes and history, leading to personalized care.

The counseling process focuses on various risk factors, including environmental toxins, nutrition, and medical conditions, aiming to reduce risks that could negatively impact the woman's health or future pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception Care for the General Ob/Gyn. Arluck, JC., Mayhew, AC.[2019]

Preconception care is crucial for improving maternal outcomes and fertility awareness, yet the specific needs of infertile couples in Europe are often overlooked.

Nurses and midwives can play a vital role in identifying and addressing the preconception care needs of infertile couples, particularly during infertility investigations or assisted conception planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception care for infertile couples: Nurses' and midwives' roles in promoting better maternal and birth outcomes. Allan, HT., Mounce, G., Crespo, E., et al.[2019]

Women at higher risk for complications during pregnancy, such as older age or a history of pregnancy loss, can significantly benefit from preconception counseling to minimize risks to both mother and baby.

Preconception counseling helps inform these women about potential risks and available options, which can only be effectively utilized if discussed before conception, highlighting the physician's role in facilitating this process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconceptional counseling. Taysi, K.[2007]

A web-based intervention for Italian women planning pregnancy significantly improved knowledge and behaviors related to preconception health, with a notable increase in folic acid supplementation and a decrease in alcohol consumption after 6 months.

The study found that 71% of participants had a preconception visit with a physician, which was linked to a higher likelihood of taking folic acid, suggesting that integrating web interventions with traditional care could enhance preconception health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cohort study of a tailored web intervention for preconception care. Agricola, E., Pandolfi, E., Gonfiantini, MV., et al.[2021]

A study of 268 Iranian couples undergoing infertility treatment revealed significant gaps in preconception counseling, with over 76% not receiving guidance on lifestyle and 90% lacking information on sexual health and psychosocial aspects.

The findings indicate a critical need for improved education and counseling practices in fertility clinics to enhance treatment outcomes and support for couples facing infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preconception counseling in couples undergoing fertility treatment. Nekuei, N., Nasr Esfahani, MH., Kazemi, A.[2020]

Preconception care is essential for all women of reproductive age, regardless of their immediate plans to conceive, as it helps identify and address various health risks.

Key elements of preconception care include risk assessment, health promotion, and the development of a reproductive life plan, which can be delivered in primary care settings and community programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for preconception care. Lu, MC.[2022]

In a study involving 170 women, a preconception care program identified an average of 8.96 risk factors per woman, highlighting the prevalence of various risks associated with pregnancy readiness.

Despite informing women and their clinicians about these risks, there was no significant increase in the rate of interventions to address them, suggesting the need for more structured systems to improve preconception care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. Jack, BW., Culpepper, L., Babcock, J., et al.[2006]

A new personalized multidisciplinary model of preconception care was proposed to help identify and reduce risks associated with adverse reproductive events, focusing on couples from various backgrounds, including those with infertility or previous reproductive issues.

The study highlights that preconception care is often overlooked in Italy, and improving awareness and counseling could lead to better maternal and fetal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Before Is Better: Innovative Multidisciplinary Preconception Care in Different Clinical Contexts. Cristodoro, M., Dell'Avanzo, M., Ghio, M., et al.[2023]

Only 20.61% of the 131 women surveyed in a Nigerian study were aware of preconception care, indicating a significant gap in knowledge about this important intervention for improving pregnancy outcomes.

Despite the low awareness, 88.46% of women who were unaware of preconception care expressed willingness to accept it if offered, suggesting a positive perception and the need for increased education and integration of preconception care into maternal healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness and perception of preconception care among women in Usmanu Danfodiyo University Teaching Hospital Sokoto, North-Western Nigeria. Umar, AG., Nasir, S., Tunau, K., et al.[2023]

Only 47.7% of women surveyed in Isfahan received preconception care, indicating a significant gap in this important health intervention before pregnancy.

The study found that factors such as education level, income, and whether the pregnancy was planned influenced the likelihood of receiving preconception care, with unplanned pregnancies being the main reason for not seeking care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of preconception care, its relation with recipients' individuality, fertility, and the causes of lack of checkup in women who gave birth in Isfahan hospitals in 2016. Shadab, P., Nekuei, N., Yadegarfar, G.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05924464

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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1592246/

Preconception Care for Improving Perinatal Outcomes Interventions designed to lower preconception risks are known collectively as preconception care. These interventions are characterized by the need to start—and ...

3. aafp.org aafp.org/about/policies/all/preconception-care.html

Preconception Care (Position Paper) This position paper discusses family physicians' critical role in preconception care and offers evidence-based recommendations to address reproductive care.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748925001439

Preconception Education: Landscape, Gaps, Future Directions Preconception educational interventions demonstrated positive impacts on women's knowledge, attitudes, behaviors, mental health, and biometric indicators.

5. cdc.gov cdc.gov/mmwr/preview/mmwrhtml/rr5506a1.htm

Recommendations to Improve Preconception Health and ... One study has reported the effectiveness of comprehensive preconception care; however, the findings have limited applicability for the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678374/

Effectiveness of preconception interventions in primary care Primary care-based preconception care (PCC) has the potential to improve pregnancy outcomes, but the effectiveness is unclear.

7. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2019/01/prepregnancy-counseling

Prepregnancy Counseling Prepregnancy counseling should include a review of a patient's immunizations, an assessment for immunity, and other screenings and tests, as appropriate.