Split Cohort Trial Comparing IVF Outcomes After the Use of Testicular vs. Ejaculated Sperm for ICSI
Stopped early
Conditions studied: Infertility
In brief
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 ejaculated sperm in couples with elevated sperm DNA fragmentation after a failed in vitro fertilization (IVF) cycle
Key facts
- Study ID
- NCT03483298
- Run by
- Reproductive Medicine Associates of New Jersey
- People needed
- 7
- Starts
- 2018-06-23
- Expected to finish
- 2021-12-31
- Last updated by the study team
- 2022-01-28
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- IVI RMA New Jersey — Basking Ridge, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.