N/A
Completed N=88
Embryo Culture Under Constant 5% vs Gradient 8%, 5%, 2% Oxygen Concentration
Embryonic Development · Embryo Morphokinetics · Embryo Morphometry
Source: ClinicalTrials.gov NCT05898178 ↗
Enrolled (actual)
88
Serious AEs
—
Results posted
Jun 2025
Primary outcomePrimary: Proportion of Inseminated Oocytes Developed to the Morphologically Optimal Blastocysts on Day 5 — 27; 38 Oocytes
Summary
The purpose of this study is to investigate the development of human embryos in vitro under two different oxygen concentrations; a static 5% during all five days of culture or under an oxygen gradient, starting with 8% from day-0 to day-3, continuing with 5% on day-3 and following with 2% of oxygen from the end of day-3 to day-5.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Inseminated Oocytes Developed to the Morphologically Optimal Blastocysts on Day 5 |
27; 38 | — |
| SECONDARY Measured Times From Insemination to Different Embryonic Stages Reached |
11.4; 11.7; 25.7; 25.7; 36.6; 35.1 | — |
| SECONDARY Blastocyst and Inner Cell Mass (ICM) Surface Area Measurement on Day 5 |
25994; 28198; 3695; 3628 | — |
| SECONDARY Number of Trophectoderm Cells on Day 5 |
14.4; 15.3 | — |
| SECONDARY Incidence of Atypical Embryo Cleavages |
36; 49; 25; 30; 14; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Age of women between 18 and 35 years.
- Body mass index (BMI) between 18 and 30 kg/m².
- Only patients with ICSI procedure (male factor of infertility, excluding azoospermia) and blastocyst culture.
- Patients from first and second ICSI cycle attempt.
- Gonadotropin hormone-releasing hormone (GnRH) antagonist cycles.
Exclusion Criteria
- Presence of endometriosis.
- Previous clinical intervention on ovaries.
- Connected endocrine or metabolic diseases.
- Presence of polycystic ovary syndrome.
Data sourced from ClinicalTrials.gov (NCT05898178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.