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

140 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Group Preconception Care for Infertility?

Research shows that preconception education and counseling can improve the success of fertility treatments by enhancing fertility awareness and addressing health risks before pregnancy. This approach is beneficial for couples undergoing fertility treatment, as it helps in planning and preparing for a healthy pregnancy. ^{1 2 3 4 5}

Is Group Preconception Care safe for humans?

Preconception care, including counseling and education, is generally considered safe for humans. It aims to reduce risks and improve health outcomes for both mothers and babies by addressing factors like nutrition, medical conditions, and lifestyle before pregnancy. ^{1 3 6 7 8}

How is Group Preconception Care for Infertility different from other treatments for infertility?

Group Preconception Care for Infertility is unique because it focuses on preparing individuals for pregnancy by addressing biomedical, behavioral, and social risks before conception, rather than treating infertility directly. This approach involves education and counseling in a group setting, which can enhance fertility awareness and promote better maternal and birth outcomes. ^{2 3 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

I plan to become pregnant myself without using a surrogate.

I am willing to be assigned to a specific care group before pregnancy.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Iran pubmed.ncbi.nlm.nih.gov

Preconception counseling in couples undergoing fertility treatment. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Recommendations for preconception care. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Preconception care for infertile couples: Nurses' and midwives' roles in promoting better maternal and birth outcomes. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Before Is Better: Innovative Multidisciplinary Preconception Care in Different Clinical Contexts. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. [2006]

6. United States pubmed.ncbi.nlm.nih.gov

Preconceptional counseling. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Preconception Care for the General Ob/Gyn. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A cohort study of a tailored web intervention for preconception care. [2021]

9. India pubmed.ncbi.nlm.nih.gov

Awareness and perception of preconception care among women in Usmanu Danfodiyo University Teaching Hospital Sokoto, North-Western Nigeria. [2023]

10. India 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. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Preconception care--when and what: the attitude of Israeli gynaecologists to preconception counseling. [2022]