Subcutaneous Catheter for IVF Stimulation in Female Infertility

Not currently recruiting at 1 trial location

Overseen By Richard J Paulson, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Southern California

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to simplify IVF (in-vitro fertilization) treatments. Instead of enduring daily or twice-daily painful injections during ovarian stimulation, the study uses a special device called the Neria Guard subcutaneous catheter. The researchers aim to determine if this device can reduce the physical and emotional stress of the treatment. Women undergoing IVF who have been prescribed controlled ovarian stimulation might be suitable candidates for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to innovative IVF advancements.

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 the Neria Guard subcutaneous catheter is safe for IVF stimulation?

Research shows that using a small tube under the skin, like the Neria Guard, for IVF (in-vitro fertilization) is generally safe. Studies on this method have not identified major safety issues. This tube simplifies the process of daily or twice-daily injections during ovarian stimulation, reducing stress.

Previous research has shown that using these tubes in IVF does not significantly affect pregnancy rates when guided by ultrasound. Evidence also indicates that patients tolerate these tubes well.

In summary, the Neria Guard subcutaneous catheter appears to offer a safer and less stressful option for ovarian stimulation in IVF, with no major side effects reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the Neria™ Guard subcutaneous catheter for IVF stimulation because it offers a new delivery method that could make the process easier and more comfortable for patients. Unlike traditional methods that often involve multiple injections, this catheter allows for a simpler and potentially less painful administration of IVF medications. By improving the ease of medication delivery, this approach could enhance patient compliance and overall experience during IVF cycles.

What evidence suggests that the Neria Guard subcutaneous catheter is effective for IVF stimulation in female infertility?

Research shows that the Neria Guard catheter might ease ovarian stimulation in IVF. Early results suggest this catheter can deliver medication without daily or twice-daily injections. Although detailed effectiveness data remains limited, the catheter aims to simplify the process and potentially enhance the patient experience. Studies have found that the type of catheter used during IVF does not significantly affect pregnancy rates when ultrasound guidance is applied. This trial tests whether the Neria Guard can make IVF easier for participants. ^{1 2 3 4 6}

Who Is on the Research Team?

Richard J Paulson, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for women aged 18 to 45 who are undergoing controlled ovarian stimulation as part of in-vitro fertilization (IVF) treatment. There are no specific exclusion criteria mentioned, so it appears open to all women within this age range and treatment category.

Inclusion Criteria

I am a woman aged 18-45 undergoing fertility treatment.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Stimulation

Participants undergo ovarian stimulation using the Neria™ Guard subcutaneous catheter

9-12 days

Daily monitoring visits

Oocyte Retrieval and Embryo Transfer

Oocytes are retrieved and embryos are transferred

1-2 weeks

1 visit for oocyte retrieval, 1 visit for embryo transfer

Follow-up

Participants are monitored for clinical pregnancy and other outcomes

1-2 weeks following embryo transfer

1-2 visits for pregnancy confirmation

What Are the Treatments Tested in This Trial?

Interventions

• IVF with the Neria Guard Subcutaneous Catheter

Trial Overview

The study is testing the use of the Neria™ Guard Subcutaneous Catheter during IVF treatments. The goal is to see if using this catheter can make taking medications easier and less stressful compared to daily injections typically used in these procedures.

How Is the Trial Designed?

Group I: IVF with Neria™ Guard device Experimental Treatment 1 Intervention

Patients undergoing IVF with the use of the Neria™ Guard subcutaneous catheter

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

ConvaTec Inc.

Industry Sponsor

Trials

52

Recruited

5,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05505474

Use of a Subcutaneous Catheter for Controlled Ovarian ...

This is a feasibility study to evaluate the use of the Neria Guard™ (Unomedical, Convatec) subcutaneous catheter for ovarian stimulation in IVF. Detailed ...

2.

withpower.com

withpower.com/trial/phase-infertility-female-11-2022-5cc5c

Subcutaneous Catheter for IVF Stimulation in Female ...

The research suggests that the choice of catheter during embryo transfer in IVF does not significantly affect pregnancy rates when ultrasound guidance is used, ...

3.

fertstert.org

fertstert.org/article/S0015-0282(23)01202-5/pdf

INJECTION-FREE CONTROLLED OVARIAN STIMULATION

MATERIALS AND METHODS: This is a pilot study of 10 patients under- going COS, both first and repeat cycles, using the Neria Guard subcutaneous.

4.

clinicaltrial.be

clinicaltrial.be/en/details/15379?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Use of a Subcutaneous Catheter for Controlled Ovarian Sti...

This study aims to assess the feasibility of a subcutaneous catheter in patients undergoing ovarian stimulation for IVF. Primary outcomes will ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38945426/

Feasibility and efficacy of a subcutaneous catheter for ...

Feasibility and efficacy of a subcutaneous catheter for controlled ovarian stimulation.

6.

bmcwomenshealth.biomedcentral.com

bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03337-z

Comparing the outcomes of in-vitro fertilization in patients ...

This study was conducted to investigate the clinical outcomes, side effects, and patient satisfaction associated with vaginal, subcutaneous, and ...