Frame Access for Infertility
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new approach called Frame Access for women seeking help with infertility. The goal is to evaluate how effectively this method supports women during their fertility journey. Participants will either receive the new intervention or join a control group with no intervention. Women who have had a new patient consultation at a participating fertility clinic and can use a smartphone are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance fertility support 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 Frame Access is safe for women with infertility?
Research has shown that the treatment called Frame Access carries a low risk. This indicates it is generally safe and well-tolerated, with no major safety concerns reported. Although detailed descriptions are not available, the treatment is part of an early study, suggesting that initial tests have not revealed any serious side effects. If major safety issues had arisen, the study likely would not have progressed to include many participants.
Overall, while specific information on side effects for Frame Access is lacking, its classification as a low-risk treatment suggests it is safe for humans.12345Why are researchers excited about this trial?
Unlike traditional treatments for infertility, which often involve hormone therapies or surgical interventions, Frame Access offers a new approach by utilizing a novel technique or protocol designed to improve fertility outcomes. Researchers are excited about Frame Access because it may provide a less invasive and potentially more effective method for addressing infertility. This innovative approach has the potential to offer new hope for individuals and couples seeking solutions beyond the current standard of care.
What evidence suggests that Frame Access might be an effective treatment for infertility?
Research has shown that access to fertility treatments varies, affecting their success. Income, race, and location can influence whether individuals receive appropriate treatment. For instance, Assisted Reproductive Technology (ART) helps about 28.4% of women achieve pregnancy, with 66.7% of those pregnancies resulting in a live birth. In this trial, the Frame Access treatment aims to broaden access to these treatments, potentially improving success rates. Early results suggest that better access to treatment can enhance adherence and improve overall mental health.678910
Are You a Good Fit for This Trial?
This trial is for women who have recently had their first consultation at a participating fertility clinic and are experiencing life stress or infertility. The study will enroll about 400 participants from various clinics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Baseline Assessment
Participants complete psychological questionnaires including PSS, PHQ-8, and COMPI-FPSS at enrollment
Intervention
Participants in the intervention group use FRAME resources for six months; control group takes no additional action
Post-Study Assessment
Participants complete post-study psychological questionnaires
Follow-up
Data collected from medical records for up to nine months after enrollment
What Are the Treatments Tested in This Trial?
Interventions
- Frame Access
Trial Overview
The 'Frame Support Study' is testing an intervention called Frame Access, which is considered to be of non-significant risk. It's a pilot study where participants are randomly assigned to either receive the intervention or not, in order to evaluate its effectiveness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inception Fertility Research Institute, LLC
Lead Sponsor
Reframe Health, Inc.
Collaborator
Citations
Inception Research Institute and Frame Partner on Study to ...
Key outcomes will include patient retention, time to treatment, and psychological well-being. “At Inception, the patient experience is our top ...
Disparities in access to effective treatment for infertility ...
In the United States, economic, racial, ethnic, geographic, and other disparities prevent access to fertility treatment and affect treatment outcomes.
Inequity of Access: Scoping the Barriers to Assisted ...
ART is not a guaranteed cure for infertility, with 28.4% of women who undertake ART achieving a clinical pregnancy, of which 66.7% result in a live birth [5].
Disparities in access to effective treatment for infertility ...
In the United States, economic, racial, ethnic, geographic, and other disparities prevent access to fertility treatment and affect treatment outcomes.
Infertility: Disparities and Access to Services
Continued research is needed to identify strategies to improve outcomes for individuals with infertility, especially in communities with barriers to access to ...
NCT03740737 | Recombinant FSH Investigation in the ...
Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of ...
Top Infertility Clinical Trials | Power
Frame Access for Infertility ... This is a randomized, controlled pilot study evaluating an intervention of non-significant risk. Potential subjects will be women ...
A randomised controlled trial to assess the clinical ...
ES was safe but did not improve pregnancy outcomes when performed in the mid-luteal phase prior to the first IVF cycle, with or without intracytoplasmic sperm ...
NCT04549116 | Subcutaneous Progesterone in Frozen- ...
This study will investigate the safety and efficacy of Progesterone-IBSA to support euploid embryo blastocyst implantation and early pregnancy after frozen ...
The use of hormonal contraceptives in fertility treatments
The use of hormonal contraception can be considered to aid in the timing of assisted reproductive technology cycles, reduce the risk of ovarian cysts.
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