Comparison of Culture Media for in Vitro Embryo Development

NCT02846012 | Completed

• 1 other identifier: 2016-NxGeM-01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Pregnancy Success

  Live Birth

  2 years

Secondary Outcomes (2)

• Implantation

  2 years

• Embryo Development

  2 years

Study Arms (2)

CSCM Control

NO INTERVENTION

Control medium

CSCM2

EXPERIMENTAL

New Formulation medium

Other: CSCM2

Interventions

CSCM2 OTHER

CSCM2

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ovation Fertility: lead

Study Sites (1)

Ovation Fertility - Austin

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Matthew VerMilyea, PhD

  Ovation Fertility

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Director

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 27, 2016
• Study Start: May 1, 2016
• Primary Completion: December 22, 2017
• Study Completion: December 22, 2017
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)