Subcutaneous Catheter for IVF Stimulation in Female Infertility

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

100 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

Research Team

Richard J Paulson, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. China pubmed.ncbi.nlm.nih.gov

[Effect of catheter choice during embryo transfer on the clinical outcome of in vitro fertilization-embryo transfer]. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Firm versus soft embryo transfer catheters under ultrasound guidance: does catheter choice really influence the pregnancy rates? [2020]

3. England pubmed.ncbi.nlm.nih.gov

Intrauterine administration of human chorionic gonadotropin (hCG) for subfertile women undergoing assisted reproduction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The choice of embryo transfer catheter affects embryo implantation after IVF. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Prophylactic antibiotics and endocervical microbial inoculation of the endometrium at embryo transfer. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

The J-Tip Needle-Free Injection System in controlled ovarian hyperstimulation in in vitro fertilization: a pilot study. [2008]

8. England pubmed.ncbi.nlm.nih.gov

Comfort, ease of use and practicality of the pen injector for follitropin α for assisted reproduction: an observational post-marketing study in Egypt. [2015]