Use of a Subcutaneous Catheter for Controlled Ovarian Stimulation

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05505474
Study type	Observational
Source	University of Southern California
Contact	Rachel S Mandelbaum, MD
Phone	6264409161
Email	rachel.mandelbaum@med.usc.edu
Status	Recruiting
Phase
Start date	November 2, 2023
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05969574` - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting	`NCT05358483` - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting	`NCT05969795` - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support	Phase 1
Recruiting	`NCT06051201` - Innovation for Small-scale Experiments: ReceptIVFity Test	N/A
Completed	`NCT03177538` - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders	Phase 4
Completed	`NCT03638856` - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy	N/A
Completed	`NCT04052464` - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn	`NCT04753736` - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC	N/A
Completed	`NCT03349905` - Deferred Versus Fresh Embryo Transfers	N/A
Completed	`NCT05076981` - Progesterone Levels During Ovulation and Luteal Phase
Completed	`NCT04096027` - Cabergoline Before or After Oocyte Collection for Follicular Resolution	Phase 4
Recruiting	`NCT05980091` - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.	Phase 1
Terminated	`NCT01933633` - Improved Fertility After Exercise in Overweight/Obese Women	N/A
Terminated	`NCT01202643` - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF	Phase 1/Phase 2
Completed	`NCT01202656` - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)	Phase 1/Phase 2
Completed	`NCT01408615` - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation	`NCT05698550` - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET	Phase 3
Not yet recruiting	`NCT03910582` - Personalized FET in RIF Patients With Displaced Dating	N/A
Completed	`NCT05440019` - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed	`NCT05130125` - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer