The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst

NCT03817671 | Unknown

• 1 other identifier: GFCST11991
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical outcome of Ultra-low oxygen tension on post thawed human blastocyst

Conditions

Embryo Development

Keywords

Thawed blastocyst; ultra low oxygen tension; 2%O2; Degree of expansion

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy rate

  Defined as the pregnancy that is confirmed by both high levels of hCG and ultrasound confirmation of a gestational sac or heartbeat

  Time frame: 15 days following embryo transfer

Secondary Outcomes (1)

• Ongoing pregnancy rate

  Time frame: 20 weeks of gestation

Study Arms (2)

Control arm (5% O2)

OTHER

After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 5% O2, and 89.3% N2 till embryo transfer

Other: 5% O2

Experimental arm (2%O2)

EXPERIMENTAL

After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 2% O2, and 92.3% N2 till embryo transfer

Other: 2% O2

Interventions

5% O2 OTHER

Culturing embryos in 5% O2 just after thawing and till embryo transfer

Control arm (5% O2)

2% O2 OTHER

Culturing embryos in 2% O2 just after thawing and till embryo transfer

Experimental arm (2%O2)

Eligibility Criteria

• Age: 5 Days - 6 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Single or Multiple Embryo transfer embryo transfer. Female age 18-40. Embryo vitrified on day 5 or day 6 of insemination.

You may not qualify if:

• Use of sperm donation. Use of Oocyte donation. Use of gestational carrier. Uterine congenital anomalies. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previously known uterine infection.
• Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.

Sponsors & Collaborators

• Ganin Fertility Center: lead

Study Sites (1)

Ganin Fertility Center

Cairo, Egypt

RECRUITING

Related Publications (8)

• Swain JE, Carrell D, Cobo A, Meseguer M, Rubio C, Smith GD. Optimizing the culture environment and embryo manipulation to help maintain embryo developmental potential. Fertil Steril. 2016 Mar;105(3):571-587. doi: 10.1016/j.fertnstert.2016.01.035. Epub 2016 Feb 3.

  PMID: 26851765 BACKGROUND

• Gardner DK. The impact of physiological oxygen during culture, and vitrification for cryopreservation, on the outcome of extended culture in human IVF. Reprod Biomed Online. 2016 Feb;32(2):137-41. doi: 10.1016/j.rbmo.2015.11.008. Epub 2015 Nov 25.

  PMID: 26687905 BACKGROUND

• Morin SJ. Oxygen tension in embryo culture: does a shift to 2% O2 in extended culture represent the most physiologic system? J Assist Reprod Genet. 2017 Mar;34(3):309-314. doi: 10.1007/s10815-017-0880-z. Epub 2017 Feb 8.

  PMID: 28181051 BACKGROUND

• Oliveira JB. Does embryo culture at low oxygen tension improve ART outcomes? JBRA Assist Reprod. 2017 Feb 1;21(1):1. doi: 10.5935/1518-0557.20170001. No abstract available.

  PMID: 28333022 BACKGROUND

• Kaser DJ, Bogale B, Sarda V, Farland LV, Williams PL, Racowsky C. Randomized controlled trial of low (5%) versus ultralow (2%) oxygen for extended culture using bipronucleate and tripronucleate human preimplantation embryos. Fertil Steril. 2018 Jun;109(6):1030-1037.e2. doi: 10.1016/j.fertnstert.2018.02.119.

  PMID: 29935641 BACKGROUND

• Ng KYB, Mingels R, Morgan H, Macklon N, Cheong Y. In vivo oxygen, temperature and pH dynamics in the female reproductive tract and their importance in human conception: a systematic review. Hum Reprod Update. 2018 Jan 1;24(1):15-34. doi: 10.1093/humupd/dmx028.

  PMID: 29077897 BACKGROUND

• Yang Y, Xu Y, Ding C, Khoudja RY, Lin M, Awonuga AO, Dai J, Puscheck EE, Rappolee DA, Zhou C. Comparison of 2, 5, and 20 % O2 on the development of post-thaw human embryos. J Assist Reprod Genet. 2016 Jul;33(7):919-27. doi: 10.1007/s10815-016-0693-5. Epub 2016 Mar 23.

  PMID: 27007876 BACKGROUND

• Leese HJ. Human embryo culture: back to nature. J Assist Reprod Genet. 1998 Sep;15(8):466-8. doi: 10.1023/a:1022526219202. No abstract available.

  PMID: 9785193 BACKGROUND

Study Officials

• Hosam Zaki, MSc, FRCOG

  Ganin Fertility Center, Cairo, Egypt.

  STUDY CHAIR

• Salma El Tanbouly, BSc.

  Ganin Fertility Center, Cairo, Egypt.

  PRINCIPAL INVESTIGATOR

• Abd El Ghafar Hussin, BSc.

  Ganin Fertility Center, Cairo, Egypt.

  PRINCIPAL INVESTIGATOR

• Hanaa El Khedr

  Ganin Fertility Center, Cairo, Egypt.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hosam Zaki, MSc, FRCOG

CONTACT

00201222150018; hosamz@tedata.net

Salma El Tanbouly, BSc.

CONTACT

00201279655807; salmaeltanbouly@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Embryologist

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: November 20, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 28, 2019

Record last verified: 2019-01

Locations

EG (1)