100 Participants Needed

Subcutaneous Catheter for IVF Stimulation in Female Infertility

Recruiting at 1 trial location
RS
RJ
Overseen ByRichard J Paulson, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a small tube placed under the skin to deliver medication for IVF patients. It aims to reduce the physical and emotional burden of frequent injections by providing continuous medication delivery. The study will check safety, patient satisfaction, and IVF outcomes.

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.

How is the Neria Guard Subcutaneous Catheter treatment for IVF different from other treatments?

The Neria Guard Subcutaneous Catheter is unique because it allows for the administration of IVF medications through a small tube placed under the skin, which may offer a more comfortable and less invasive option compared to traditional needle injections.12345

What data supports the effectiveness of the treatment using the Neria Guard Subcutaneous Catheter for IVF stimulation in female infertility?

The research suggests that the choice of catheter during embryo transfer in IVF does not significantly affect pregnancy rates when ultrasound guidance is used, which may imply that the type of catheter, like the Neria Guard, could be effective as long as it minimizes difficult transfers and endometrial injury.13678

Who Is on the Research Team?

RJ

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?
1Treatment groups
Experimental Treatment
Group I: IVF with Neria™ Guard deviceExperimental Treatment1 Intervention
Patients undergoing IVF with the use of the Neria™ Guard subcutaneous catheter

Find a Clinic Near You

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

[Effect of catheter choice during embryo transfer on the clinical outcome of in vitro fertilization-embryo transfer]. [2018]
Firm versus soft embryo transfer catheters under ultrasound guidance: does catheter choice really influence the pregnancy rates? [2020]
Intrauterine administration of human chorionic gonadotropin (hCG) for subfertile women undergoing assisted reproduction. [2022]
The choice of embryo transfer catheter affects embryo implantation after IVF. [2019]
Prophylactic antibiotics and endocervical microbial inoculation of the endometrium at embryo transfer. [2022]
The importance of the length of uterine cavity, the position of the tip of the inner catheter and the distance between the fundal endometrial surface and the air bubbles as determinants of the pregnancy rate in IVF cycles. [2016]
The J-Tip Needle-Free Injection System in controlled ovarian hyperstimulation in in vitro fertilization: a pilot study. [2008]
Comfort, ease of use and practicality of the pen injector for follitropin α for assisted reproduction: an observational post-marketing study in Egypt. [2015]
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