NCT02999958

Brief Summary

Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species. This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation. It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use. The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

December 3, 2018

Status Verified

November 1, 2018

Enrollment Period

1.4 years

First QC Date

December 16, 2016

Last Update Submit

November 30, 2018

Conditions

Culture MediaBlastocystAntioxidantsEmbryoHumanOxygen

Outcome Measures

Primary Outcomes (1)

  • Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5

    7 months

Secondary Outcomes (7)

  • Embryo development on day 3, 5 & 6

    7 months

  • Embryo quality on day 3, 5 & 6

    7 months

  • Total blastocyst rate

    7 months

  • Blastocyst utilization rate per fertilized oocyte

    7 months

  • Biochemical pregnancy rate

    8 months

  • +2 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Sequential culture media without addition of antioxidants

Treatment

ACTIVE COMPARATOR

Sequential culture media with the addition of antioxidants

Biological: Antioxidants

Interventions

AntioxidantsBIOLOGICAL

In the Treatment Arm, the G-Series culture media system will be used with antioxidants

Also known as: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC), alpha-Lipoic acid (ALA)
Treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Minimum eight cumulus-oocyte-complexes.
  • Couples with female, male or unexplained infertility intending to undergo IVF
  • The couple should have received verbal and written information/consent about the study.
  • Blastocyst culture and embryo transfer is decided.
  • If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal.

You may not qualify if:

  • Previous participation in the study
  • PGD/PGS
  • Surgically retrieved sperm cells (TESA / TESE)
  • If split IVF is needed
  • Less than eight cumulus-oocyte-complexes
  • More than thirty cumulus-oocyte-complexes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kuramoto Women´s Clinic

Fukuoka, 8120013, Japan

Location

Kiba Park Clinic

Tokyo, 135-0042, Japan

Location

Related Publications (1)

  • Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.

    PMID: 10856474RESULT

MeSH Terms

Interventions

AntioxidantsAcetylcarnitineAcetylcysteineThioctic Acid

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of ChemicalsCarnitineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsCysteineAmino Acids, SulfurSulfur CompoundsAmino AcidsAmino Acids, Peptides, and ProteinsCarboxylic AcidsThiophenesCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • A Yoshida, MD, PhD

    Kiba Park Clinic, Tokyo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2016

First Posted

December 21, 2016

Study Start

December 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

December 3, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(2)