Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate

Effectiveness of Single Step Culture Media and Sequential Culture Media on Blastulation Rate: a Randomized Controlled Trial.

To compare the effectiveness of single step culture media and continuous uninterrupted culture media on blastulation rate

Study Overview

• Status: Withdrawn
• Conditions: Infertility
• Intervention / Treatment: Drug: Global; Drug: Origio

Detailed Description

Sequential culture media are designed to mimic the changing environment in the ovary ducts and the uterus in vivo. However, there are some differences between in vivo and in vitro culture conditions. Hence, single step media are created which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest higher blastulation rate in the single step media than the sequential media.

This is an Randomized controlled trial (RCT) study comparing the blastulation rate of single step culture media and sequential culture media. Stimulation protocol is antagonist. Patient will be consulted on the day of ultrasound if they meet the inclusion criteria and sign the consent form. Then, the nurse will open the letter containing the type of media for that case. The media is prepared inside the lab a day before oocyte pick-up.

After oocyte pick-up, the oocyte-cumulus complex (OCC) will be cultured for 2 hours at 37°C, 6% Carbon dioxide (CO2) and 5% oxygen (O2). Meanwhile, sperm preparation will be performed using gradient technique. After 2 hours, OCC will be denuded and will be cultured for 1 hour until Intracytoplasmic Sperm Injection (ICSI). Oocytes after ICSI will be cultured in groups of 3-4 oocytes in the same conditions of 37 ° C, 6% CO2 and 5% O2. Fertilization check procedure is at 16-18 hours after ICSI. On day 3, the embryos will be evaluated in 66-68 hours after ICSI, grade 1 embryos are identified with 7-9 blastomeres and fragmentation is from 0-10%. The patients will be informed about the embryo quality. If the embryos are not decided to have day 5 transferring, patient will be consulted to transfer on day 3. Blastulation rate will not be recorded.

For the sequential culture media group, embryos will be transferred to Sequential Blast medium. For the single step culture media group, embryos will be transferred to the new culture dish with the same medium. On day 5, embryo quality assessment will be at 116±1 hours after ICSI. Blastocyst grading is based on the expansion, inner cell mass quality, and trophectoderm quality. Two good blastocyst will be transferred. After 11 days, beta-human chorionic gonadotropin (hCG) test will be required. If the beta-hCG result is positive, examination will be needed after 3 weeks and the luteal support will be given until 7 weeks.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh, Vietnam
    • My Duc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Number of previous failure IVF cycles ≤2
• Using Gonadotropin-releasing hormone (GnRH) - Antagonist protocol for IVF
• Using GnRH for oocyte triggering.
• Read and sign consent form to participate in the study and have not been recruited for any other researches.

Exclusion Criteria:

• Oocyte donation cycles
• Abnormal uterine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Global; EmbryoSingle step culture medium Embryos are cultured in single step culture from day 1 to day 5 Other Name: Global medium (LifeGlobal)	Drug: Global; Embryos are cultured in single step culture from day 1 to day 5; Other Names: Global medium (LifeGlobal)
Active Comparator: Origio; Sequential media Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast) Other Name: Sequential Blast (Origio)	Drug: Origio; Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast); Other Names: Sequential Blast (Origio)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The blastulation rate	The blastulation rate is defined as the number of blastocysts from 2 pronuclei (2PN) zygotes	116 ±1 hours after ICSI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate	Implantation rate is defined as the number of gestational sacs per number of embryos transferred.	11 days after embryo transfer
Clinical pregnancy	Clinical pregnancy is defined by the image gestational sac under ultrasonography.	7 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Vietnam National University
• Collaborators: Mỹ Đức Hospital
• Investigators: Principal Investigator: Tuong M Ho, MD, Research Center for Genetics and Reproductive Health

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: IVF; ICSI; culture media; sequential
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: NCKH/CGRH_ 05_2015