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New treatment option for Female Infertility
Official title Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes
ClinicalTrials.gov ID: NCT07500337
What this study is testing
- What it's testing
- Background: Embryo fragmentation is one of the main morphological parameters assessed during in vitro culture in assisted reproductive technology (ART). The presence of anucleate cytoplasmic fragments is commonly observed in human embryos and may negatively affect developmental potential and clinical outcomes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 42, women only
You may be able to join if
- Female patients undergoing ICSI cycles at the participating center
- Age 18-42 years
- Presence of at least one morula with cytoplasmic fragmentation ≥10% at Day 4 morphological assessment (Grade B: 10-25%, Grade C: 26-50%, Grade D...
- Embryos intended for extended culture to blastocyst stage (Day 5/Day 6)
- All embryo cultures performed in time-lapse incubator (Geri, Genea Biomedex)
You likely can't join if
- Severely reduced ovarian reserve (AMH ≤ 0.5 ng/mL)
- Body mass index (BMI) ≥ 32 kg/m²
- Diagnosis of endometriosis
- Polycystic ovary syndrome (PCOS)
- Maternal age ≥ 42 years
- History of repeated implantation failure
See the full eligibility criteria
- Female patients undergoing ICSI cycles at the participating center
- Age 18-42 years
- Presence of at least one morula with cytoplasmic fragmentation ≥10% at Day 4 morphological assessment (Grade B: 10-25%, Grade C: 26-50%, Grade D: ≥50%)
- Embryos intended for extended culture to blastocyst stage (Day 5/Day 6)
- All embryo cultures performed in time-lapse incubator (Geri, Genea Biomedex)
- Written informed consent obtained prior to any study-related procedure -
- Severely reduced ovarian reserve (AMH ≤ 0.5 ng/mL)
- Body mass index (BMI) ≥ 32 kg/m²
- Diagnosis of endometriosis
- Polycystic ovary syndrome (PCOS)
- Maternal age ≥ 42 years
- History of repeated implantation failure
- Donor gamete cycles (oocyte or sperm donation)
- Cycles with preimplantation genetic testing for monogenic disease (PGT-M) as primary indication
- Embryos with severe morphological compromise at Day 3
- Concurrent participation in other treatment studies that could interfere with study outcomes
- Inability to provide written informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Bisceglie, BT, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 42 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bisceglie, BT, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.