What side effects are associated with this type of intervention?

Common treatments for female infertility, particularly those involving subcutaneous delivery of ovarian stimulation medications like nafarelin and ganirelix, often have side effects such as local injection site reactions, nausea, headache, fatigue, and hypoestrogenic symptoms (e.g., hot flashes and bone loss). Other reported side effects include dizziness, subcutaneous hematoma, and malaise. These side effects are generally considered tolerable but can vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved various treatments for female infertility, particularly those involving controlled ovarian stimulation for in-vitro fertilization (IVF). These treatments often include subcutaneous administration of medications such as gonadotropins (e.g., FSH and LH) to stimulate the ovaries. The Neria Guard™ subcutaneous catheter is being studied as a method to simplify the administration of these medications, potentially reducing the physical and emotional burden of daily injections. This approach aligns with existing FDA-approved protocols that utilize subcutaneous delivery systems for ovarian stimulation.

What other types of research exist?

Promising alternatives to the Neria Guard™ subcutaneous catheter for ovarian stimulation in female infertility patients include: 1) Intranasal delivery systems for gonadotropin-releasing hormone (GnRH) analogues, such as nafarelin, which are non-invasive and have shown efficacy in other reproductive treatments. 2) Implantable subcutaneous infusion devices that provide chronic intravenous pulsatile GnRH administration, which have demonstrated good tissue tolerance and effective hormone distribution in preliminary studies.

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Subcutaneous Catheter for IVF Stimulation in Female Infertility

N/A

Recruiting

Led By Richard J Paulson, MD

Research Sponsored by University of Southern California

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 immediately following ovarian stimulation and oocyte retrieval

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, subcutaneous catheters may cause local skin reactions, discomfort at the insertion site, or infections. However, since this is a feasibility study, part of its purpose will be to document any potential side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during ovarian stimulation (usually 9-12 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during ovarian stimulation (usually 9-12 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during ovarian stimulation (usually 9-12 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device feasibility

Secondary study objectives

Adverse effects related to the subcutaneous catheter

Clinical pregnancy

Embryo blastulation

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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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

Common treatments for female infertility often involve the use of gonadotropins and GnRH analogs to stimulate the ovaries to produce multiple follicles. Gonadotropins, such as FSH and LH, directly stimulate the ovaries, while GnRH analogs help regulate the release of these hormones to optimize follicle development. Subcutaneous delivery systems, like the Neria Guard™ catheter, provide a more convenient and less painful method for administering these medications, which can enhance patient compliance and reduce the emotional and physical burden of treatment. This is essential for female infertility patients, as consistent and accurate medication administration is critical for the success of assisted reproductive technologies like IVF.

Nonhormonal therapy for endometriosis: a randomized, placebo-controlled, pilot study of cabergoline versus norethindrone acetate.Mild versus conventional antagonist ovarian stimulation protocols in expected normal responders undergoing IVF/ICSI: a case-control study.Mental distress and personality in women undergoing GnRH agonist versus GnRH antagonist protocols for assisted reproductive technology.