Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

NCT05505474 | Unknown DMC FDA Device

• 1 other identifier: APP-21-05650
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Device feasibility

  To measure follicle-stimulating hormone (FSH) and estradiol levels after administration of subcutaneous gonadotropins via the catheter

  During ovarian stimulation (usually 9-12 days)

Secondary Outcomes (5)

• Adverse effects related to the subcutaneous catheter

  During ovarian stimulation (usually 9-12 days)

• Patient satisfaction and acceptability

  During ovarian stimulation (usually 9-12 days)

• Number of mature oocytes retrieved

  Immediately following ovarian stimulation and oocyte retrieval

• Embryo blastulation

  5-7 days after oocyte retrieval

• Clinical pregnancy

  1-2 weeks following embryo transfer

Study Arms (1)

IVF with Neria™ Guard device

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

Device: IVF with the Neria™ Guard Subcutaneous Catheter

Interventions

IVF with the Neria™ Guard Subcutaneous Catheter DEVICE

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

IVF with Neria™ Guard device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 patients undergoing controlled ovarian stimulation

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Southern California: lead
• ConvaTec Inc.: collaborator

Study Sites (1)

HRC Fertility

Los Angeles, California, 91101, United States

RECRUITING

Related Publications (5)

• Haemmerli Keller K, Alder G, Loewer L, Faeh M, Rohner S, von Wolff M. Treatment-related psychological stress in different in vitro fertilization therapies with and without gonadotropin stimulation. Acta Obstet Gynecol Scand. 2018 Mar;97(3):269-276. doi: 10.1111/aogs.13281. Epub 2018 Jan 8.

  PMID: 29247514 BACKGROUND

• Burdick P, Cooper S, Horner B, Cobry E, McFann K, Chase HP. Use of a subcutaneous injection port to improve glycemic control in children with type 1 diabetes. Pediatr Diabetes. 2009 Apr;10(2):116-9. doi: 10.1111/j.1399-5448.2008.00449.x. Epub 2009 Jan 7.

  PMID: 19175512 BACKGROUND

• de Jong ME, Carbiere T, van den Heuvel-Eibrink MM. The use of an insuflon device for the administration of G-CSF in pediatric cancer patients. Support Care Cancer. 2006 Jan;14(1):98-100. doi: 10.1007/s00520-005-0872-x. Epub 2005 Aug 12.

  PMID: 16096770 BACKGROUND

• Hanas SR, Carlsson S, Frid A, Ludvigsson J. Unchanged insulin absorption after 4 days' use of subcutaneous indwelling catheters for insulin injections. Diabetes Care. 1997 Apr;20(4):487-90. doi: 10.2337/diacare.20.4.487.

  PMID: 9096966 BACKGROUND

• Solnica A, Oh C, Cho MM, Loughlin JS, McCulloh DH, McGovern PG. Patient satisfaction and clinical outcome after injecting gonadotropins with use of a needle-free carbon dioxide injection system for controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2009 Oct;92(4):1369-1371. doi: 10.1016/j.fertnstert.2009.03.013. Epub 2009 Apr 7.

  PMID: 19356750 BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Richard J Paulson, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel S Mandelbaum, MD

CONTACT

6264409161; rachel.mandelbaum@med.usc.edu

Richard J Paulson, MD

CONTACT

6264409161; rpaulson@med.usc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: August 17, 2022
• Study Start: November 2, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (1)