Comparison of Culture Media for in Vitro Embryo Development (NXGeM)

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: CSCM2

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Ovation Fertility - Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: CSCM Control; Control medium
EXPERIMENTAL: CSCM2; New Formulation medium	Other: CSCM2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy Success	Live Birth	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation	Presence of Gestational Sac	2 years
Embryo Development	Blastocyst Utilisation Rate (number of fertilised embryos which develop to usable blastocysts)	2 years

Collaborators and Investigators

• Sponsor: Ovation Fertility
• Investigators: Principal Investigator: Matthew VerMilyea, PhD, Ovation Fertility

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): December 22, 2017
• Study Completion (ACTUAL): December 22, 2017

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (ESTIMATE): July 27, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2016-NxGeM-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, however, collated data may be used for publication without patient identification.