Could a 'Hands-Off' embryo culture boost IVF success?
NCT ID NCT07522281
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two ways of growing embryos in the lab during IVF. One method uses a special incubator and a single culture medium that keeps embryos undisturbed. The other uses standard equipment and multiple media changes. About 478 women will take part to see if the new method leads to more pregnancies. The goal is to find out if a simpler, closed system can improve embryo quality and pregnancy rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- undisturbed embryo culture system (Geri incubator and Gems one-step culture medium)
- What this could lead to
- If successful, this could show that a simpler, undisturbed way of growing embryos in the lab leads to more successful pregnancies in IVF.
- What could go wrong
- This is an early-stage trial comparing two lab methods, not testing a new drug. The difference in pregnancy rates may be small or not meaningful for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 478 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients entering an ART cycle at the reproductive medicine center after study initiation and meeting the indications for IVF or ICSI; * No more than two previous IVF/ICSI embryo transfer cycles; * Agreement to culture all fertilized embryos to the blastocyst stage (Day 5/Day 6); * AMH ≥1.2 ng/mL and AFC ≥7; * Fewer than 20 oocytes retrieved and serum estradiol level on the day of hCG administration \<5000 pg/mL. Exclusion Criteria: * History of low fertilization rate in previous cycles (fertilization rate \<25%); * Oocyte donation or sperm donation cycles; * Either partner has a known chromosomal abnormality on karyotype analysis, or the couple plans to undergo preimplantation genetic testing (PGT); * Conditions that may affect oocyte quality, including premature ovarian insufficiency, endometriosis, ovarian endometrioma, or a history of two or more pelvic surgeries; * Requirement for surgical sperm retrieval, including microsurgical sperm retrieval or testicular sperm extraction; * Significant untreated uterine factors that may impair embryo implantation, including: submucosal uterine fibroids; two or more intramural fibroids, with the largest diameter ≥3 cm and significant compression of the uterine cavity causing cavity distortion; untreated moderate to severe intrauterine adhesions; one or more endometrial polyps with a maximum diameter ≥1.0 cm, or two or more space-occupying endometrial polyps within the uterine cavity; untreated moderate to severe hydrosalpinx (diameter ≥3 cm); * History of fertilization or oocyte maturation disorders, including fertilization - failure in a previous ICSI cycle or previous oocyte maturation disorder.
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As listed by the trial registrant
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How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
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A doctor treating you
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