What side effects are associated with this type of intervention?

Common side effects of infertility treatments like IVF include ovarian hyperstimulation syndrome (OHSS), which can cause swollen and painful ovaries, bloating, and nausea. Hormonal treatments may lead to mood swings, headaches, and abdominal pain. Emotional and psychological stress is also significant, often resulting in anxiety and depression. Surgical interventions, if needed, carry risks of infection, bleeding, and anesthesia-related complications.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of infertility, particularly those used in ovulation induction and assisted reproductive technologies like IVF. Clomiphene citrate (Clomid) and letrozole (Femara) are commonly used oral agents for inducing ovulation in women with polycystic ovary syndrome (PCOS). Gonadotropins, such as follicle-stimulating hormone (FSH) and human menopausal gonadotropin (hMG), are injectable medications used to stimulate the ovaries to produce multiple eggs. Additionally, medications like human chorionic gonadotropin (hCG) are used to trigger ovulation. These treatments are often part of comprehensive fertility plans that may include educational interventions to improve health insurance literacy and utilization of IVF benefits.

What other types of research exist?

Promising novel alternatives to educational interventions for infertility patients considering treatment in 2024 include: 1) Advanced pharmacologic agents and surgical procedures to preserve reproductive function, 2) Patient education and care programs that improve quality of life and treatment tolerability, 3) Utilization of donor eggs to improve success rates in older age groups, and 4) Lifestyle modifications to optimize spermatogenesis in male infertility. These alternatives aim to enhance patient outcomes and satisfaction while potentially reducing treatment costs.

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Health Insurance Guidance for Infertility Treatment Benefits

N/A

Waitlist Available

Led By H. Irene Su, MD MSCE

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month after receipt of the intervention

Awards & highlights

Summary

This trial evaluates a program to help people better understand their health insurance and use fertility treatment benefits. The researchers hope the program will lead to increased literacy and use of IVF.

Who is the study for?

This trial is for employees with health insurance, aged 18 to 50, who speak English or Spanish and plan to expand their family within the next year. There are no specific exclusion criteria mentioned.Check my eligibility

What is being tested?

The study is testing an educational guide designed to improve understanding of health insurance and how it can cover in vitro fertilization (IVF) treatments. The goal is to see if this guide helps people make better use of IVF benefits.See study design

What are the potential side effects?

Since this trial involves an educational intervention rather than a medical treatment, there are no direct physical side effects associated with participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month after receipt of the intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month after receipt of the intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after receipt of the intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Financial hardship

Health Insurance Literacy Measure

Insurance coverage

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Health insurance educational guideExperimental Treatment1 Intervention

Eligible individuals will receive a health insurance educational guide to support choosing among 5 health plans for IVF coverage. They will also receive receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period.

Group II: Usual careActive Control1 Intervention

Eligible individuals will receive a one-page guide with a link to the Open Enrollment website that is available to all employees during the open enrollment period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health insurance educational guide

2022

N/A

~230

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In vitro fertilization (IVF) and other assisted reproductive technologies (ART) are common treatments for infertility. IVF involves stimulating the ovaries to produce multiple eggs, retrieving these eggs, fertilizing them with sperm in a laboratory, and then transferring the resulting embryos into the uterus. This process bypasses several potential barriers to natural conception, such as fallopian tube blockages or low sperm count. Other ART methods include intracytoplasmic sperm injection (ICSI), where a single sperm is injected directly into an egg, and the use of donor eggs or sperm. These treatments are crucial for infertility patients as they offer alternative pathways to achieve pregnancy when natural conception is not possible, thereby providing hope and potential solutions for those struggling with infertility.

Duration of involuntary infertility and subsequent pregnancy.Stress and Anxiety Levels in Couples who Undergo Fertility Treatment: a Review of Systematic Reviews.The continuum of high ovarian response: a rational approach to the management of high responder patient subgroups.

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Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,135 Previous Clinical Trials

1,551,023 Total Patients Enrolled

2 Trials studying Infertility

74 Patients Enrolled for Infertility

H. Irene Su, MD MSCEPrincipal InvestigatorUniversity of California, San Diego

2 Previous Clinical Trials

216 Total Patients Enrolled

1 Trials studying Infertility

34 Patients Enrolled for Infertility

Media Library

Health insurance educational guide Clinical Trial Eligibility Overview. Trial Name: NCT05663645 — N/A

Infertility Research Study Groups: Health insurance educational guide, Usual care

Infertility Clinical Trial 2023: Health insurance educational guide Highlights & Side Effects. Trial Name: NCT05663645 — N/A

Health insurance educational guide 2023 Treatment Timeline for Medical Study. Trial Name: NCT05663645 — N/A

~83 spots leftby Jul 2025

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