Adding Antioxidants Into Human Embryo Culture Media
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 128
- Locations
- 2
- Primary Endpoint
- Percentage of good quality blastocysts (GQB) per randomized embryo
Study Overview
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.
Detailed Description
Study objective: Study comparing blastocyst development on the same cohort of oocytes using two different media, G-TL versus G-TL supplemented with antioxidants.
Primary endpoint: Percentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.
Secondary endpoints
- Embryo development day 3, 5 and 6
- Embryo quality day 3, 5 and 6
- Total blastocyst formation (day 5 and day 6)
- Utilization rate (embryos available for transfer and cryopreservation)
- Implantation rate
- Clinical pregnancy rate
Setup: Prospective embryo sibling, superiority study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 41 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Couples with female, male or unexplained infertility intending to undergo IVF
- •The couple should have received verbal and written information/consent about the study.
- •6 or more fertilized oocytes on day 1
- •Blastocyst culture and transfer on day 5
- •Signed written consent
Exclusion Criteria
- •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
Arms & Interventions
Control
Culture media without addition of antioxidants
Treatment
Culture media with the addition of antioxidants
Intervention: Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA) (Biological)
Outcomes
Primary Outcomes
Percentage of good quality blastocysts (GQB) per randomized embryo
Time Frame: 7 months
Secondary Outcomes
- Embryo development (Kinetics) day 3,5 & 6(7 months)
- Pregnancy rate(10 months)
- Implantation rate(8 months)
- Embryo quality dag 3,5 and 6(7 months)
- Utilization rate(7 months)
- Total blastocyst rate(7 months)
Investigators
Thorir Hardarson
Laboratory Director
Fertilitetscentrum AB