Split Cohort Trial Comparing IVF Outcomes After the Use of Testicular vs. Ejaculated Sperm for ICSI

Launched by REPRODUCTIVE MEDICINE ASSOCIATES OF NEW JERSEY · Mar 23, 2018

Keywords

ClinConnect Summary

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 routine IVF treatment will be contacted for possible study participation.
2. Informed consent will be obtained
3. The primary investigator will be notified of the couple's participation.
4. The male partner will cryopreserve an ejaculated semen sample if there is no cryopreserved ejaculated specimen in inventory. The male partner will undergo a surgical sperm retrieval (TESA) and the specimen will be...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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

Trial Officials