Infertility Clinical Trial
Official title:
Prospective Observational Study Utilizing Next Generation Continuous Single Culture Media (CSCM2) for Comparative in Vitro Embryo Development and Outcome Data
The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.
A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients.
Patients will be enrolled from participating sites from the United States. Study sites will
conduct this study under the oversight of Sterling IRB. Each study site should enroll enough
patients to achieve at least 50 evaluable patients that have undergone a treatment cycle
using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the
other half in current CSCM (as control).
The methods will consist of standard ovarian stimulation protocols at each facility to obtain
a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following
fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated
to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to
standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%)
to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and
monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur
in a fresh or frozen cycle.
The procedures in this study are designed to follow the standard medical care at each study
site for women having IVF treatment (the participant will sign a separate consent at your
clinic for your IVF procedures). The participants study doctor will explain in detail the
procedures participants will undergo at the clinic; this form is only meant to explain the
details of the research study. This study does not involve randomization of patient
participation or any sham procedures.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A |