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| Name | Class |
|---|---|
| ConvaTec Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVF with Neria™ Guard device | Patients undergoing IVF with the use of the Neria™ Guard subcutaneous catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVF with the Neria™ Guard Subcutaneous Catheter | Device | Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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100 patients undergoing controlled ovarian stimulation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel S Mandelbaum, MD | Contact | 6264409161 | rachel.mandelbaum@med.usc.edu | |
| Richard J Paulson, MD | Contact | 6264409161 | rpaulson@med.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Richard J Paulson, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HRC Fertility | Recruiting | Los Angeles | California | 91101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29247514 | Background | 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. | |
| 19175512 | Background |
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We plan to publish and share deidentified data of primary and secondary outcomes.
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| 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. |
| 16096770 | Background | 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. |
| 9096966 | Background | 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. |
| 19356750 | Background | 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. |
| D000091662 | Genital Diseases |
| D007246 | Infertility |