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NCT03964805: EmbryOx
Oxygen Tension on Human Embryonic Development
NA trial testing 20% oxygen in Infertility in 773 participants. Completed in 1 December 2018.
6 September 2018
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 773 |
| Start date | 1 September 2016 |
| Primary completion | 6 September 2018 |
| Estimated completion | 1 December 2018 |
Drugs / interventions tested
- 20% oxygen
- 5% oxygen
- 20 % and 5 % oxygen
Conditions studied
- Infertility — all drugs for Infertility →
- Embryo Culture — all drugs for Embryo Culture →
- Hypoxia — all drugs for Hypoxia →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 39, any sex, with Infertility or Embryo Culture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In mammals, uterine environment is at low oxygen concentration (2-8% O2). Thus, human embryo culture under low O2 tension (5%) is now recommended by European Society of Human Reproduction and Embryology (ESHRE) revised guidelines for good practices in in vitro fertilization (IVF) labs. Indeed, hypoxia seems to improve embryo quality at cleavage and blastocyst stages, presumably by reducing damages of oxidative stress (OS). Nevertheless, recent meta-analyses concluded only with a low evidence to a superiority of hypoxia on IVF/ICSI outcomes. Furthermore, a study on mouse embryos suggested a negative impact of OS only at cleavage stage. The aim of the present prospective randomized study was to investigate this hypothesis for the first time in human embryos.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of oxygen tension according to embryo stage of development: a prospective randomized study.
Herbemont C, Labrosse J, Bennani-Smires B, Cedrin-Durnerin I, et al · · 2021 · cited 9× · PMID 34785697 · DOI 10.1038/s41598-021-01488-9
Verify or expand the search:
- PubMed search for NCT03964805
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03964805 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 28 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03964805.
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