Investigating how the zona pellucida affects fertilization success in IVF
Official title: To Investigate the Relationship Between the Viscoelastic Properties of the Zona Pellucida of Human Oocyte and the Blastocyst Utilization Rate
Run by Inti Labs · NCT06839495 · Data updated 2026-11-12
This study is testing how the stiffness of the outer layer of eggs affects the success of fertilization in people undergoing IVF.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 38 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Inti Labs Industry-sponsored |
| Locations | 1 site (Taichung) |
| Status | Recruiting |
| Started | July 31, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | February 21, 2025 |
| Trial ID | NCT06839495 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 38 or younger undergoing IVF treatment with a sufficient oocyte count and appropriate hormone levels.
✕Probably not a fit
Patients with untreated uterine abnormalities, extreme BMI, or those using donated gametes will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study examines the relationship between the viscoelastic properties of the zona pellucida surrounding human oocytes and the rate of blastocyst utilization in in vitro fertilization (IVF). Using a non-invasive device called OPAL X1, the study measures the physical rigidity of the zona pellucida to assess oocyte quality prior to fertilization. The device applies pressure through a micropipette and records the movement of the zona pellucida, which is then analyzed to determine its properties. The findings aim to enhance understanding of factors influencing fertilization success.
Why it matters
Potential benefit: If successful, this study could improve IVF outcomes by providing a better assessment of oocyte quality.
How similar studies have gone: While the approach of measuring viscoelastic properties in oocytes is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women who have started the in vitro fertilization (IVF) treatment and related examinations. 2. Female participants aged ≤38 years with an anti-Müllerian hormone (AMH) concentration greater than 1.1 ng/mL and a collected oocyte count of more than 10. 3. Participants who consent to undergoing IVF with intracytoplasmic sperm injection (ICSI) and time-lapse embryo culture. Exclusion Criteria: 1. Women diagnosed with untreated uterine abnormalities as assessed by a physician. 2. Participants with a body mass index (BMI) outside the range of 18.5-30 kg/m\^2. 3. Patients undergoing IVF using sperm retrieved through surgical extraction. 4. Patients undergoing IVF using donated oocytes or donated sperm.
Where it's running
-
Lee Women's Hospital
Taichung, Taiwan Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluating a non-invasive test for endometrial receptivity in patients with implantation failure
This study is testing a new blood test called the Ora test to see if it can help couples who have had trouble with embryo implantation during IVF by finding the best time for embryo transfer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.