Recruiting

Subcutaneous Catheter

Sponsor:

University of Southern California

Code:

NCT05505474

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

IVF with the Neria™ Guard Subcutaneous Catheter

Study Details

Brief summary:

Subcutaneous medications are an integral part of controlled ovarian stimulation protocols for in-vitro fertilization (IVF), but daily or twice daily injections are both physically and emotionally burdensome for patients and their partners. This is a feasibility study to evaluate the use of the Neria Guard™ (Unomedical, Convatec) subcutaneous catheter for ovarian stimulation in IVF.

Conditions

Infertility, Female

Study ID

NCT05505474

Start date

Nov 2, 2023

Status verified date

Nov, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Female between 18 and 45 years of age undergoing controlled ovarian stimulation

Exclusion Criteria:

  • none

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

IVF with Neria™ Guard device

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

Interventions

IVF with the Neria™ Guard Subcutaneous Catheter

Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle.

Primary outcome measure

  • Device feasibility [ Time Frame: During ovarian stimulation (usually 9-12 days) ]

Central Contacts and Locations

Central contacts

Rachel S Mandelbaum, MD

6264409161rachel.mandelbaum@med.usc.edu

Richard J Paulson, MD

6264409161rpaulson@med.usc.edu

Locations

HRC Fertility

Recruiting

Los Angeles, California, United States, 91101

Contacts

Rachel S Mandelbaum, MD

310-902-8277rachel.mandelbaum@med.usc.edu

More Information

Sponsor

University of Southern California

Last update posted

Nov 18, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2023-11-18.