Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

Conditions
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Infertility, Female

Intervention / Treatment
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* Device: IVF with the Neria™ Guard Subcutaneous Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female between 18 and 45 years of age undergoing controlled ovarian stimulation Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| IVF with Neria™ Guard device<br>Patients undergoing IVF with the use of the Neria™ Guard subcutaneous catheter | Device: IVF with the Neria™ Guard Subcutaneous Catheter<br>* Use of the Neria™ Guard subcutaneous catheter for administration of subcutaneous medication in an IVF cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 |