Infertility, Female
Conditions
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.
Interventions
DEVICEIVF with the Neria™ Guard Subcutaneous Catheter
Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle.
Sponsors
ConvaTec Inc.
University of Southern California
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Female between 18 and 45 years of age undergoing controlled ovarian stimulation
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactRachel S Mandelbaum, MD
Backup ContactRichard J Paulson, MD
Outcome results
None listed