Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Device: IVF with the Neria™ Guard Subcutaneous Catheter

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.

• Study Type: Observational
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel S Mandelbaum, MD; Phone Number: 6264409161; Email: rachel.mandelbaum@med.usc.edu
• Study Contact Backup: Name: Richard J Paulson, MD; Phone Number: 6264409161; Email: rpaulson@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91101
      • Recruiting
      • HRC Fertility
      • Contact: Rachel S Mandelbaum, MD; Phone Number: 310-902-8277; Email: rachel.mandelbaum@med.usc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

100 patients undergoing controlled ovarian stimulation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects related to the subcutaneous catheter	Catheter malfunction, number of times needed to administer traditional needle injection, need for premature catheter exchange or removal, emergency pages to the clinic for catheter-related issues, local issue reactions, pain, bleeding, hematoma, infection	During ovarian stimulation (usually 9-12 days)
Patient satisfaction and acceptability	Patient satisfaction will be evaluated via a self-designed pre- and post-cycle questionnaire to quantify pre-cycle needle phobia, satisfaction with the catheter system, reasons for continuation or discontinuation. The questionnaires will be preapproved by the University of California Institutional Review Board.	During ovarian stimulation (usually 9-12 days)
Number of mature oocytes retrieved	The number of oocytes in metaphase II retrieved at the time of oocyte retrieval	Immediately following ovarian stimulation and oocyte retrieval
Embryo blastulation	The number of embryos that progress to blastocyst per the number fertilized	5-7 days after oocyte retrieval
Clinical pregnancy	As defined by a intrauterine gestational sac between weeks 5 and 6	1-2 weeks following embryo transfer

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: ConvaTec Inc.
• Investigators: Principal Investigator: Richard J Paulson, MD, University of Southern California

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: APP-21-05650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to publish and share deidentified data of primary and secondary outcomes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes