Comparisons of Human Embryonic Development Using Single Medium With and Without the Addition of Antioxidants

NCT02971878 | Completed DMC

• 1 other identifier: GTL-X
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: To investigate the impact of antioxidants (acetyl-L-carnitine, N-acetyl-L-cysteine and a-lipoic acid) on embryo development and subsequently the clinical outcome. Including clinics using low oxygen and ambient air during embryo culture. Analysed with time-lapse system. Study media: G-TL with antioxidants. Control media: Same media without antioxidants. Type of study: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants. Statistics based on an absolute increase in Good Quality Blastocysts on day 5 of 7%. Design: Multicentre prospective randomized sibling trial. Single blastocyst transfer. Superiority study Primary Endpoint: Good Quality Blastocysts on day 5 per allocated normally fertilized oocyte. Patients: Comparative embryo sibling study with 128 patients included.

Conditions

Culture Media; Blastocyst; Antioxidants; Embryo; Human

Outcome Measures

Primary Outcomes (1)

• Percentage of good quality blastocysts (GQB) per randomized embryo

  7 months

Secondary Outcomes (6)

• Pregnancy rate

  10 months

• Utilization rate

  7 months

• Embryo development (Kinetics) day 3,5 & 6

  7 months

• Implantation rate

  8 months

• Embryo quality dag 3,5 and 6

  7 months

Study Arms (2)

Control

NO INTERVENTION

Culture media without addition of antioxidants

Treatment

ACTIVE COMPARATOR

Culture media with the addition of antioxidants

Biological: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)

Interventions

Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA) BIOLOGICAL

Human embryos will be cultured in media that contains 3 antioxidants (Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)) that can be found in the in vivo Environment.

Treatment

Eligibility Criteria

• Age: 20 Years - 41 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Couples with female, male or unexplained infertility intending to undergo IVF
• The couple should have received verbal and written information/consent about the study.
• or more fertilized oocytes on day 1
• Blastocyst culture and transfer on day 5
• Signed written consent

You may not qualify if:

• Previous participation in the study.
• Testicular biopsy patients (TESA/TESE)
• Fewer than 6 fertilized oocytes.
• If split IVF is needed.
• Total freeze on day 3

Sponsors & Collaborators

• Fertilitetscentrum AB: lead
• Vitrolife: collaborator

Study Sites (1)

Fertilitetscentrum

Gothenburg, Box 5418, 40229, Sweden

Location

MeSH Terms

Interventions

Acetylcarnitine; allantoicase; Acetylcysteine

Intervention Hierarchy (Ancestors)

Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Thorir Hardarson, PhD

  Fertilitetscentrum AB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory Director

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

SE (1)