Status:
ACTIVE_NOT_RECRUITING
Microfluidics Versus Gradient Centrifugation Effect on Euploidy Rates
Lead Sponsor:
Lawrence Engmann
Collaborating Sponsors:
The Center for Advanced Reproductive Services, P.C.
ZyMot Fertility
Conditions:
Infertility
Recurrent Pregnancy Loss
Eligibility:
FEMALE
18-42 years
Phase:
NA
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 ...
Detailed Description
As part of the in vitro fertilization (IVF) process, eggs are removed from the ovaries and are inseminated (mixed) or injected with sperm. In order for fertilization to occur, the sperm cells must be ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04744025
Start Date
January 13 2021
End Date
December 31 2022
Last Update
October 3 2022
Active Locations (1)
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1
The Center for Advanced Reproductive Services
Farmington, Connecticut, United States, 06032