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Development of a 3D-Printed Tool to Help Remove Cells Around Eggs Used in IVF Research.

Development and evaluation of a three dimensional printed cumulus denudation pipette for oocyte processing in assisted reproductive technology - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105688
Enrollment
70
Registered
2026-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Use of 3D Printed Cumulus Denudation Pipette for Oocyte Denudation in Assisted Reproductive Techniques (ART): 1. Design and Fabrication A cumulus denudation pipette is designed using

Sponsors

Dr Aysha M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cumulus Oocyte Complexes (COCs) retrieved from bovine ovaries obtained from slaughterhouse or research facility under approved protocols. 2. Oocytes with intact cumulus cell layers (minimum 2 3 layers of compact cumulus cells). 3. Morphologically normal oocytes with: Uniform cytoplasm, Homogeneous ooplasm, Intact zona pellucida 4. Oocytes collected from healthy bovine ovaries without visible pathological changes (cysts, degeneration, infection). 5. Oocytes aspirated from follicles measuring approximately 2 8 mm in diameter (optimal follicular size for quality oocytes). 6. Freshly collected oocytes processed within acceptable time frame (usually within 2 4 hours of ovary retrieval). 7. Oocytes suitable for in vitro maturation (IVM) or denudation procedures.

Exclusion criteria

Exclusion criteria: 1. Oocytes with damaged or ruptured zona pellucida. 2. Degenerated or atretic oocytes showing: Dark or fragmented cytoplasm, Irregular ooplasm, Vacuolization 3. COCs with absent or sparse cumulus cell layers (poor quality or denuded oocytes). 4. Oocytes obtained from overmature or very small follicles (outside optimal follicular size range). 5. Oocytes subjected to delayed processing beyond acceptable laboratory time limits. 6. Oocytes showing mechanical damage during aspiration or handling. 7. Contaminated oocytes (microbial or debris contamination).

Design outcomes

Primary

MeasureTime frame
Oocyte Survival Rate After Cumulus Denudation Definition The proportion of bovine oocytes that remain morphologically intact and viable following mechanical denudation using the study pipette. Assessment Parameters Integrity of zona pellucida Intact oolemma (no rupture or lysis) Normal cytoplasmic appearance Absence of mechanical damageTimepoint: Baseline: Before denudation procedure (assessment of oocyte with intact cumulus cells). Immediately after denudation: Assessment of completeness of cumulus cell removal using the three dimensional printed pipette. Post procedure assessment (within the same laboratory session): Evaluation of denudation efficiency and oocyte integrity.

Secondary

MeasureTime frame
1. Time Required for Oocyte Denudation Duration taken to achieve complete removal of cumulus cells per oocyte. 2. Ease of Handling & Operator Satisfaction Assessment of ergonomics, comfort, & precision during use by embryologists. 3. Structural Integrity of Pipette Evaluation of durability & resistance to deformation during repeated use. 4. Reusability & Sterilization Efficiency Ability of the pipette to withstand sterilization cycles without affecting performance. 5. Cost-Effectiveness Comparison of production & maintenance cost with commercially available pipettes. 6. Reproducibility of Design Consistency in pipette dimensions & performance across multiple 3D printed batches.Timepoint: 1. Time taken for complete oocyte denudation Time Points: Assessed during each denudation procedure at baseline, 4 weeks, & 8 weeks of the study period. 2. Oocyte morphological integrity after denudation Time Points: Evaluated immediately after denudation at baseline, 4 weeks, & 8 weeks. 3. Oocyte survival rate following denudation Time Points: Assessed immediately post procedure at baseline, 4 weeks, & 8 weeks.

Countries

India

Contacts

Public ContactDr AYSHA M

Saveetha Medical College and Hospital

nidhisharma.smc@saveetha.com9445560392

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026