Infertility Clinical Trial
Official title:
Lo2 Phase II: A Comparison of Live Birth Rates Between Embryos Cultured in 2% vs. 5% After Day 3 of Embryo Culture
Verified date | May 2021 |
Source | Reproductive Medicine Associates of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | January 31, 2021 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Reproductive Medicine Associates of New Jersey | Instituto Universitario IVI |
United States,
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;(7):CD008950. doi: 10.1002/14651858.CD008950.pub2. Review. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live Birth Rate | Delivery of a fetus after 20 weeks of gestation (WHO definition) | through study completion, an average of 1 year | |
Secondary | Miscarriage Rate | Number of pregnancy losses after visualization of a gestational sac and yolk sac on ultrasound | through study completion, an average of 1 year | |
Secondary | Gestational Age at delivery | The number of weeks gestation completed prior to delivery of the fetus | through study completion, an average of 1 year | |
Secondary | Birthweight at delivery | Weight in grams of fetus at time of delivery | through study completion, an average of 1 year | |
Secondary | Embryo blastulation rate | Number of embryos that progress to the blastocyst developmental stage per fertilized ova | through study completion, an average of 1 year | |
Secondary | Embryo ploidy status | The percentage of embryos that are deemed euploidy by preimplantation genetic screening | through study completion, an average of 1 year | |
Secondary | Embryo morphologic parameters | Assignment of morphologic grade of embryos (as per modified Gardner's criteria) | through study completion, an average of 1 year | |
Secondary | Cumulative live birth rate | The number of live births (per definition above) achieved from all embryos derived from the in vitro fertilization cycle involved in the study for a given patient | through study completion, an average of 1 year |
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