Clinical trial NCT05505474: Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation
Official title: Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility, Female
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2022-08-17
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 patients undergoing controlled ovarian stimulation

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: Device feasibility
timeFrame: During ovarian stimulation (usually 9-12 days)
Secondary outcomes:
measure: Adverse effects related to the subcutaneous catheter
timeFrame: During ovarian stimulation (usually 9-12 days)
measure: Patient satisfaction and acceptability
timeFrame: During ovarian stimulation (usually 9-12 days)
measure: Number of mature oocytes retrieved
timeFrame: Immediately following ovarian stimulation and oocyte retrieval
measure: Embryo blastulation
timeFrame: 5-7 days after oocyte retrieval
measure: Clinical pregnancy
timeFrame: 1-2 weeks following embryo transfer
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: HRC Fertility
state: California
Study officials:
affiliation: University of Southern California
name: Richard J Paulson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.