Status:
TERMINATED
Split Cohort Trial Comparing IVF Outcomes After the Use of Testicular vs. Ejaculated Sperm for ICSI
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility
Eligibility:
MALE
18-65 years
Brief Summary
The primary objective of this study is to determine if there is a difference in in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) outcomes when using testicular sperm versus ej...
Detailed Description
The experimental design for this study is as follows: 1. Couples with male partners who will be undergoing a TESA procedure secondary to elevated DNA fragmentation (\>25% DFI) as part of their routin...
Eligibility Criteria
Inclusion
- Willing to comply with all study procedures and be available for the duration of the study
- Failed at least one IVF cycle (i.e., no live birth)
- Elevated DNA fragmentation noted in ejaculated sperm (\>25% DFI according to the American Society of Reproductive Medicine guidelines)
- Couple electing single embryo transfer
- Couples electing comprehensive chromosome screening (CCS) of embryos
- At least 4 oocytes retrieved in IVF cycle in order to randomize
Exclusion
- Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- Contraindication to IVF
- Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis)
- Male partner with azoospermia (\<100,000 motile spermatozoa)
- Male partner with Y-chromosome microdeletion
- Male partner with any Karyotype other than 46,XY(normal male karyotype)
- Female partner history of hydrosalpinges or adnexal mass
- Female partner history of endometrial insufficiency (max endometrial thickness \< 7mm)
- Female partner BMI \< 35
Key Trial Info
Start Date :
June 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03483298
Start Date
June 23 2018
End Date
December 31 2021
Last Update
January 28 2022
Active Locations (1)
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1
IVI RMA New Jersey
Basking Ridge, New Jersey, United States, 07920