Infertility Clinical Trial
Official title:
Performance Study of New Media for Vitrification of Human Oocytes
The purpose of this study is to evaluate safety and performance of Vitrolife´s new oocyte vitrification/warming media and the vitrification device Rapid-i™, when using vitrification as a cryopreservation method for human oocytes.
A multi-center prospective sibling oocyte vitrification trial where, in the first phase,
half of the patients' oocytes will be vitrified and warmed (experimental group). The
remaining oocytes will not be vitrified and will serve as the control group. In the second
phase all of the patients' oocytes will be vitrified and the embryo transfer will be
performed in a following cycle. This simulates the situation of a normal cryopreservation
embryo transfer. The study population consists of 20 women who will undergo a fresh IVF
cycle during the study period. The primary objective in the first phase is to assess
survival, fertilization and embryo development after oocyte vitrification/warming with the
new media. The results will be compared with results from sibling oocytes which have not
been vitrified. Secondary objectives are to assess the clinical results such as
implantation, miscarriage and pregnancy rate as well as delivery rate and neonatal outcome.
The primary objective in the second phase is to assess the delivery rate after oocyte
vitrification/warming with the new media. Secondary objectives are to assess survival,
fertilization, embryo development, utilization rate, pregnancy rate and neonatal outcome on
the previously vitrified and warmed oocytes. The results will be compared with results from
a control group of patients, treated at the same clinics within the same time period, using
the same inclusion and exclusion criteria. All patients who undergo embryo transfer will
have a serum beta-hCG test conducted 14 days after oocyte retrieval. If positive, repeat
beta-hCG testing will be conducted 2-4 days later. If appropriate, a pregnancy ultrasound
will be conducted between 6-8 weeks gestation (menstrual age) to record gestational sac(s)
and fetal heart beat. The delivery outcome will also be recorded. For patients with an
unsuccessful treatment, there will be a follow-up period of 6 months after study completion.
From this follow-up, data from frozen cycles, i.e. from embryos after oocyte vitrification,
can be evaluated as well.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
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 |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A |