NCT03147872

Brief Summary

Clinical in vitro fertilization relies on successful embryo culture. The primary goal of embryo culture is to attempt to recapitulate the in vivo conditions as much as possible. In the past decade, the majority embryo culture has been performed at 5% oxygen due to the discovery that the oxygen tension in the fallopian tube (where the embryo is located for the first 3 days after fertilization) is 5%. However, relatively recent studies have demonstrated that the oxygen tension in the uterus (where the embryo is located after day 3) is closer to 2%. This study is a randomized controlled trial that will compare pregnancy rates between embryos cultured in 2% versus 5% after day 3 of development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

May 8, 2017

Last Update Submit

May 18, 2021

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    Delivery of a fetus after 20 weeks of gestation (WHO definition)

    through study completion, an average of 1 year

Secondary Outcomes (7)

  • Miscarriage Rate

    through study completion, an average of 1 year

  • Gestational Age at delivery

    through study completion, an average of 1 year

  • Birthweight at delivery

    through study completion, an average of 1 year

  • Embryo blastulation rate

    through study completion, an average of 1 year

  • Embryo ploidy status

    through study completion, an average of 1 year

  • +2 more secondary outcomes

Study Arms (2)

5% Oxygen

NO INTERVENTION

All patients' embryos will be cultured in 5% oxygen from day 1 through 3 of development. After day 3 of development, patients randomized to this arm will continue to have their embryos cultured at 5% oxygen until they are deemed to be clinically usable or not clinically usable (as per standard protocol).

2% Oxygen

EXPERIMENTAL

All patients' embryos will be cultured in 5% oxygen from day 1 through 3 of development. After day 3 of development, patients randomized to this arm will have their embryos cultured at 2% oxygen until they are deemed to be clinically usable or not clinically usable (per standard criteria).

Other: 2% Oxygen

Interventions

2% OxygenOTHER

2% oxygen concentration in the incubator in which embryos are being cultured after day 3 of development

2% Oxygen

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGenotypically female (with functioning ovaries)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Anti-mullerian hormone level (AMH) \> 1.0 ng/mL
  • Must have at least one surviving embryo on day three of development
  • Male partner with \>100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
  • Body Mass Index \< 35

You may not qualify if:

  • Diagnosis of endometrial insufficiency, as defined by prior cycle with maximal endometrial thickness \<6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), or persistent endometrial fluid
  • Use of oocyte donation
  • Use of gestational carrier
  • Use of sperm obtained via surgical procedure
  • Presence of hydrosalpinges that communicate with endometrial cavity
  • Single gene disorders, chromosomal translocations or any other disorders requiring more detailed embryo genetic analysis
  • Couples seeking gender selection for family balancing
  • Completion of the protocol requires a single embryo transfer of an embryo as part of the study. Thus, patients pursuing embryo banking cycles will be excluded from the study.
  • Double embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (5)

  • Fischer B, Bavister BD. Oxygen tension in the oviduct and uterus of rhesus monkeys, hamsters and rabbits. J Reprod Fertil. 1993 Nov;99(2):673-9. doi: 10.1530/jrf.0.0990673.

    PMID: 8107053BACKGROUND

  • 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: 22786519BACKGROUND

  • Gardner DK, Wale PL. Analysis of metabolism to select viable human embryos for transfer. Fertil Steril. 2013 Mar 15;99(4):1062-72. doi: 10.1016/j.fertnstert.2012.12.004. Epub 2013 Jan 8.

    PMID: 23312219BACKGROUND

  • Rinaudo PF, Giritharan G, Talbi S, Dobson AT, Schultz RM. Effects of oxygen tension on gene expression in preimplantation mouse embryos. Fertil Steril. 2006 Oct;86(4 Suppl):1252-65, 1265.e1-36. doi: 10.1016/j.fertnstert.2006.05.017.

    PMID: 17008149BACKGROUND

  • 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: 18927130BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Scott Morin, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

  • Daniel J Kaser, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Patients and care providers will be masked as to which embryo is randomized to each condition. Investigators will be masked until the data are analyzed.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 10, 2017

Study Start

May 15, 2017

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

May 19, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)