NCT05924048

Brief Summary

To assess the effect of reducing the oxygen concentration from 5% to 2% on Intracytoplasmic sperm injection (ICSI) outcome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2024

Completed
Last Updated

July 11, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

June 18, 2023

Last Update Submit

July 8, 2023

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

  • Number and grad of embryos which exposed to oxygen concentration 2% .

    Evaluate embryo quality at day 5

    1.3 year

Secondary Outcomes (1)

  • Clinical pregnancy rate for examined subject.

    1.5 Year

Study Arms (2)

Group of 2% oxygen concentration.

EXPERIMENTAL

Incubate human embryo at 2% oxygen concentration.

Other: Reducing the Oxygen Concentration From 5% to 2%

Group of 5% oxygen concentration.

NO INTERVENTION

Incubate human embryo at 5% oxygen concentration.

Interventions

Reducing the Oxygen Concentration From 5% to 2%OTHER

Effect of Reducing the Oxygen Concentration From 5% to 2% in arm 1.

Group of 2% oxygen concentration.

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Female age 20-35 years. Oocytes with normal morphology.

You may not qualify if:

  • Embryo number less than 5. Male factor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Islamic Center

Cairo, 11511, Egypt

RECRUITING

Related Publications (11)

  • Bahceci M, Ciray HN, Karagenc L, Ulug U, Bener F. Effect of oxygen concentration during the incubation of embryos of women undergoing ICSI and embryo transfer: a prospective randomized study. Reprod Biomed Online. 2005 Oct;11(4):438-43. doi: 10.1016/s1472-6483(10)61136-4.

    PMID: 16274603RESULT

  • Bontekoe S, Mantikou E, van Wely M, Seshadri S, Repping S, Mastenbroek S. Low oxygen concentrations for embryo culture in assisted reproductive technologies. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008950. doi: 10.1002/14651858.CD008950.pub2.

    PMID: 22786519RESULT

  • Christianson MS, Zhao Y, Shoham G, Granot I, Safran A, Khafagy A, Leong M, Shoham Z. Embryo catheter loading and embryo culture techniques: results of a worldwide Web-based survey. J Assist Reprod Genet. 2014 Aug;31(8):1029-36. doi: 10.1007/s10815-014-0250-z. Epub 2014 Jun 10.

    PMID: 24913025RESULT

  • Gomes Sobrinho DB, Oliveira JB, Petersen CG, Mauri AL, Silva LF, Massaro FC, Baruffi RL, Cavagna M, Franco JG Jr. IVF/ICSI outcomes after culture of human embryos at low oxygen tension: a meta-analysis. Reprod Biol Endocrinol. 2011 Nov 1;9:143. doi: 10.1186/1477-7827-9-143.

    PMID: 22044493RESULT

  • Guerin P, El Mouatassim S, Menezo Y. Oxidative stress and protection against reactive oxygen species in the pre-implantation embryo and its surroundings. Hum Reprod Update. 2001 Mar-Apr;7(2):175-89. doi: 10.1093/humupd/7.2.175.

    PMID: 11284661RESULT

  • Dumoulin JC, Meijers CJ, Bras M, Coonen E, Geraedts JP, Evers JL. Effect of oxygen concentration on human in-vitro fertilization and embryo culture. Hum Reprod. 1999 Feb;14(2):465-9. doi: 10.1093/humrep/14.2.465.

    PMID: 10099995RESULT

  • 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: 29935641RESULT

  • Kea B, Gebhardt J, Watt J, Westphal LM, Lathi RB, Milki AA, Behr B. Effect of reduced oxygen concentrations on the outcome of in vitro fertilization. Fertil Steril. 2007 Jan;87(1):213-6. doi: 10.1016/j.fertnstert.2006.05.066. Epub 2006 Nov 1.

    PMID: 17081523RESULT

  • Kovacic B, Sajko MC, Vlaisavljevic V. A prospective, randomized trial on the effect of atmospheric versus reduced oxygen concentration on the outcome of intracytoplasmic sperm injection cycles. Fertil Steril. 2010 Jul;94(2):511-9. doi: 10.1016/j.fertnstert.2009.03.077. Epub 2009 May 5.

    PMID: 19409544RESULT

  • Meintjes M, Chantilis SJ, Douglas JD, Rodriguez AJ, Guerami AR, Bookout DM, Barnett BD, Madden JD. A controlled randomized trial evaluating the effect of lowered incubator oxygen tension on live births in a predominantly blastocyst transfer program. Hum Reprod. 2009 Feb;24(2):300-7. doi: 10.1093/humrep/den368. Epub 2008 Oct 16.

    PMID: 18927130RESULT

  • Nastri CO, Nobrega BN, Teixeira DM, Amorim J, Diniz LMM, Barbosa MWP, Giorgi VSI, Pileggi VN, Martins WP. Low versus atmospheric oxygen tension for embryo culture in assisted reproduction: a systematic review and meta-analysis. Fertil Steril. 2016 Jul;106(1):95-104.e17. doi: 10.1016/j.fertnstert.2016.02.037. Epub 2016 Mar 21.

    PMID: 27012651RESULT

Central Study Contacts

Ahmed El Sayed Sabry

CONTACT

01098609545ahmedsabry7787@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2023

First Posted

June 29, 2023

Study Start

January 1, 2023

Primary Completion

January 27, 2024

Study Completion

March 25, 2024

Last Updated

July 11, 2023

Record last verified: 2023-06

Locations

EG(1)