Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

NCT ID: NCT05505474

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-02
• Study Completion Date: 2024-12-31

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.

Detailed Description

Daily or twice daily injections are a standard part of controlled ovarian stimulation for in-vitro fertilization (IVF). These injections are both physically and emotionally burdensome for patients and contribute additional stressors to those already inherent to infertility. Subcutaneous catheters have been demonstrated to be effective for administration of insulin, anticoagulants, and other medications in pediatric patients, and subcutaneous gonadotropin-releasing hormone pumps have also been used in hypothalamic patients. This study aims to assess the feasibility of a subcutaneous catheter in patients undergoing ovarian stimulation for IVF. Primary outcomes will include the incidence of safety and catheter-related issues as well as assessment of patient satisfaction in cycles using the subcutaneous catheter. We will also closely monitor estradiol and follicle-stimulating hormone levels during stimulation to ensure adequate medication administration via the catheter as well as IVF outcomes including mature oocyte yield, embryo maturation, and pregnancy rates.

Conditions

Infertility, Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

IVF with Neria™ Guard device

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

IVF with the Neria™ Guard Subcutaneous Catheter

Intervention Type: DEVICE

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

Interventions

IVF with the Neria™ Guard Subcutaneous Catheter

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Richard Paulson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Paulson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

HRC Fertility

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel S Mandelbaum, MD

Role: CONTACT

rachel.mandelbaum@med.usc.edu

6264409161

Richard J Paulson, MD

Role: CONTACT

rpaulson@med.usc.edu

6264409161

Facility Contacts

Rachel S Mandelbaum, MD

Role: primary

rachel.mandelbaum@med.usc.edu

310-902-8277

References

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.

Reference Type: BACKGROUND

PMID: 29247514 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19175512 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16096770 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9096966 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19356750 (View on PubMed)

Other Identifiers

APP-21-05650

Identifier Type: -

Identifier Source: org_study_id