Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

Infertility, Female Clinical Trial

Official title:

Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05505474
• Other study ID #: APP-21-05650
• Status: Recruiting
• Start date: November 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Southern California
• Contact: Rachel S Mandelbaum, MD
• Phone: 6264409161
• Email: rachel.mandelbaum[@]med.usc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Device:
• IVF with the Neria™ Guard Subcutaneous Catheter
Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle.

Locations

Country	Name	City	State
United States	HRC Fertility	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	ConvaTec Inc.

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	Embryo blastulation	The number of embryos that progress to blastocyst per the number fertilized	5-7 days after oocyte retrieval
Secondary	Clinical pregnancy	As defined by a intrauterine gestational sac between weeks 5 and 6	1-2 weeks following embryo transfer