Investigating how the zona pellucida affects fertilization success in IVF
To Investigate the Relationship Between the Viscoelastic Properties of the Zona Pellucida of Human Oocyte and the Blastocyst Utilization Rate
Inti Labs · NCT06839495
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | N/A to 38 Years |
| Sex | Female |
| Sponsor | Inti Labs (industry) |
| Locations | 1 site (Taichung) |
| Trial ID | NCT06839495 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 38 or younger undergoing IVF treatment with a sufficient oocyte count and appropriate hormone levels.
Not a fit: Patients with untreated uterine abnormalities, extreme BMI, or those using donated gametes will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Taichung
- Lee Women's Hospital — Taichung, Taiwan (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oocyte, Zona Pellucida, Viscoelastic Property