Infertility Clinical Trial
— LO2Official title:
Evaluation of the Impact of Reduced Oxygen Concentration on Embryonic Development
Verified date | June 2018 |
Source | Reproductive Medicine Associates of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
During this study, patients will undergo a routine in vitro fertilization cycle as they would otherwise if not participating in the study. After eggs have been fertilized they will be cultured as usual until day 3 of embryo development. On day 3 of development, the embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration and the other half at 5%, which is currently the standard of care. All other embryological care procedures will remain the same. On day 5 or 6 of embryo development, the embryos will be evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be the blastulation rate (or percentage of embryos that reach the blastocyst stage).
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2018 |
Est. primary completion date | February 10, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-40 years and seeking IVF with aneuploidy screening, which is our current recommendation regardless of study participation 2. Anti-mullerian hormone level (AMH) > 1.0 pmol/L (an assessment of ovarian reserve) 3. Must have at least two surviving embryos on day 3 of development 4. Male partner with >100,000 total motile spermatozoa per ejaculate (donor sperm acceptable) 5. Body Mass Index < 35 Exclusion Criteria: 1. 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 2. Use of oocyte donation 3. Use of gestational carrier 4. Use of sperm obtained via surgical procedure 5. Presence of hydrosalpinges that communicate with endometrial cavity 6. Single gene disorders, chromosomal translocations or any other disorders requiring more detailed embryo genetic analysis 7. Couples seeking gender selection for family balancing |
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 |
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Live birth rate | Delivery of an alive baby will be the criteria for live birth rate assessment | 10 months | |
Primary | Blastulation Rate (number of embryos meeting criteria for biopsy and/cryopreservation divided by number of embryos randomized on day 3 to either the experimental or control arm) | On day 5 and day 6, all embryos are examined under the microscope to see if they 1) meet developmental criteria for embryo biopsy (for chromosomal evaluation) and cryopreservation (since all embryos in this program are cryopreserved while awaiting results from chromosome assessment), or 2) arrest development in the laboratory. | 6 days of embryonic development in the laboratory | |
Secondary | Clinical Pregnancy rate | After embryos are cryopreserved, embryos with the proper number of chromosomes (so called euploid embryos) will be available for transfer to the uterus (as is standard protocol in our center). Clinical pregnancy rate will be defined by the presence of a gestational sac on ultrasound in the embryo transfer cycle. | 2 months |
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