140 Participants Needed

Group Preconception Care for Infertility

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IL
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Overseen ByAnuja Dokras, MD, PhD
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.13678

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.2391011

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.
See 1 more

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
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention armExperimental Treatment1 Intervention
Group preconception care
Group II: Control armActive Control1 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

Find a Clinic Near You

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.
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.
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.
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]

References

Preconception counseling in couples undergoing fertility treatment. [2020]
Recommendations for preconception care. [2022]
Preconception care for infertile couples: Nurses' and midwives' roles in promoting better maternal and birth outcomes. [2019]
Before Is Better: Innovative Multidisciplinary Preconception Care in Different Clinical Contexts. [2023]
Addressing preconception risks identified at the time of a negative pregnancy test. A randomized trial. [2006]
Preconceptional counseling. [2007]
Preconception Care for the General Ob/Gyn. [2019]
A cohort study of a tailored web intervention for preconception care. [2021]
Awareness and perception of preconception care among women in Usmanu Danfodiyo University Teaching Hospital Sokoto, North-Western Nigeria. [2023]
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]
Preconception care--when and what: the attitude of Israeli gynaecologists to preconception counseling. [2022]
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