Comparison of Culture Media for in Vitro Embryo Development
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 51 |
| Updated: | 12/29/2017 |
| Start Date: | May 2016 |
| End Date: | December 22, 2017 |
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.
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.
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.
Inclusion Criteria:
- At least 18 years of age in good general physical and mental health.
- Women undergoing fresh in vitro fertilization treatment using their own eggs which
will be fertilized by ICSI only
- Normal uterine cavity, as defined by the program.
- Normal BMI (< 35).
- Normal endocrine workup (including PCOS patients).
- Fresh or Frozen Blastocyst transfer
- At least 4 diploid zygotes showing signs of normal (2PN) fertilisation
- Willing to have half of their 2PN embryos cultured in CSCM and the other half of their
2PN embryos cultured in CSCM 2nd generation
- Willing to comply with study protocol and procedures
- Willing to provide written informed consent
Exclusion Criteria:
- Use of donor egg / gestational carrier
- Couples for whom the male partner requires surgically extracted sperm (testicular or
epididymal retrieval)
- History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or
estrogen.
- A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg.
allergies, immune deficiency, etc.)
- History of cancer
We found this trial at
1
site
Click here to add this to my saved trials
