Microfluidics Versus Gradient Centrifugation Effect on Euploidy Rates

NCT04744025 | Active Not Recruiting FDA Device

• 1 other identifier: 21-106R-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done to determine if using a microfluidics chamber, a device used to process sperm, will be effective in improving the rates of embryos with normal chromosomes (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that this device is effective at improving rates of normal chromosomes among embryos.

Conditions

Infertility; Recurrent Pregnancy Loss

Keywords

Microfluidics; Density gradient centrifugation; In vitro fertilization; Preimplantation genetic testing; Euploidy; Sperm processing

Outcome Measures

Primary Outcomes (1)

• Euploidy rate of resulting embryos

  Rate of embryos with normal chromosomes in both groups

  Within 2-4 weeks of IVF cycle

Secondary Outcomes (1)

• Pregnancy rates after transfer of euploid embryos

  Within 1-2 cycles of fresh IVF cycle

Other Outcomes (1)

• DNA fragmentation results

  1-2 years after initial study completed

Study Arms (2)

Microfluidics

EXPERIMENTAL

Half of participants eggs will be injected with sperm processed using a microfluidics chamber.

Device: Microfluidics chamber

Density gradient centrifugation

ACTIVE COMPARATOR

Half of participants eggs will be injected with sperm processed using a density gradient centrifugation (the standard method).

Other: Density Gradient Centrifugation

Interventions

Microfluidics chamber DEVICE

Unwashed sperm will be placed into the inlet chamber of the microfluidics device. The most motile sperm will swim to the outlet chamber, and these sperms will be used for intracytoplasmic sperm injection (ICSI) into the eggs.

Also known as: ZyMot Fertility (device brand name)

Microfluidics

Density Gradient Centrifugation OTHER

Sperm will be washed and centrifuged according to standard protocol, and these washed sperm will be used for ICSI.

Density gradient centrifugation

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Nonpregnant females underoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) and preimplantation genetic testing (PGT)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are nonpregnant females ≥ 18 years and ≤ 42 years of age.
• Subjects obtain ≥ 6 mature oocytes at the time of oocyte retrieval or at the time of ICSI.
• Subjects are utilizing ICSI for fertilization.
• Subjects are utilizing PGT-A (PGT for aneuploidy).
• Subjects are able to understand, read, and write in English at a fifth-grade level.
• Subjects are willing to comply with study protocol and procedures and provide written informed consent.

You may not qualify if:

• Subjects are utilizing donor oocytes, donor sperm, or gestational carrier.
• Subjects have a diagnosis of severe male factor infertility (sperm concentration \< 5 mil/mL at semen analysis).
• Subjects are utilizing surgically removed sperm (e.g. via testicular sperm aspiration \[TESA\] or microsurgical epididymal sperm aspiration \[MESA\]).
• Subjects are utilizing frozen/thawed sperm.
• Subjects are utilizing frozen/thawed oocytes.
• Subjects are undergoing a day 3 (cleavage stage) embryo transfer.
• Subjects obtain \< 6 mature oocytes at the time of oocyte retrieval or at the time of ICSI.
• Subjects obtain ≥ 6 mature oocytes but choose to fertilize fewer than 6 of them.
• Sperm sample parameters are low on the day of oocyte retrieval (semen volume \< 1.0 mL or concentration \< 1 million motile/mL).
• Male partner has an infectious disease.

Sponsors & Collaborators

• Lawrence Engmann: lead
• The Center for Advanced Reproductive Services, P.C.: collaborator
• ZyMot Fertility: collaborator

Study Sites (1)

The Center for Advanced Reproductive Services

Farmington, Connecticut, 06032, United States

Location

Related Publications (1)

• Godiwala P, Kwieraga J, Almanza E, Neuber E, Grow D, Benadiva C, Makhijani R, DiLuigi A, Schmidt D, Bartolucci A, Engmann L. The impact of microfluidics sperm processing on blastocyst euploidy rates compared with density gradient centrifugation: a sibling oocyte double-blinded prospective randomized clinical trial. Fertil Steril. 2024 Jul;122(1):85-94. doi: 10.1016/j.fertnstert.2024.02.021. Epub 2024 Feb 15.

  PMID: 38367686 DERIVED

Related Links

• The Center for Advanced Reproductive Services Website

MeSH Terms

Conditions

Infertility

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultracentrifugation; Centrifugation; Investigative Techniques; Chemistry Techniques, Analytical

Study Officials

• Lawrence Engmann, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

• Alison Bartolucci, PhD

  The Center for Advanced Reproductive Services, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinical providers, investigators and Outcome assessors will be blinded to outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Sibling oocyte study: Participants will have their oocytes (eggs) divided into two groups. Half of the eggs will be injected with sperm processed in the normal way, and half will be injected with sperm processed via a microfluidics chamber.

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 13, 2021
• Primary Completion: August 15, 2022
• Study Completion: December 31, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

US (1)