Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation
- Conditions
- Infertility, Female
- Interventions
- Device: IVF with the Neria™ Guard Subcutaneous Catheter
- Registration Number
- NCT05505474
- Lead Sponsor
- University of Southern California
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- Female between 18 and 45 years of age undergoing controlled ovarian stimulation
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description IVF with Neria™ Guard device IVF with the Neria™ Guard Subcutaneous Catheter Patients undergoing IVF with the use of the Neria™ Guard subcutaneous catheter
- Primary Outcome Measures
Name Time Method Device feasibility During ovarian stimulation (usually 9-12 days) To measure follicle-stimulating hormone (FSH) and estradiol levels after administration of subcutaneous gonadotropins via the catheter
- Secondary Outcome Measures
Name Time Method Adverse effects related to the subcutaneous catheter During ovarian stimulation (usually 9-12 days) 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
Patient satisfaction and acceptability During ovarian stimulation (usually 9-12 days) 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.
Number of mature oocytes retrieved Immediately following ovarian stimulation and oocyte retrieval The number of oocytes in metaphase II retrieved at the time of oocyte retrieval
Embryo blastulation 5-7 days after oocyte retrieval The number of embryos that progress to blastocyst per the number fertilized
Clinical pregnancy 1-2 weeks following embryo transfer As defined by a intrauterine gestational sac between weeks 5 and 6
Trial Locations
- Locations (1)
HRC Fertility
🇺🇸Los Angeles, California, United States