Fresh Vs Frozen Surgical Sperm in IVF

Infertility Clinical Trial

Official title:

Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03361982
• Other study ID #: RMA-2017-06
• Status: Terminated
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.

Description:

The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Females age < 42 with an indication for IVF

• Females with lowest AMH level 1.2 ng/mL or higher

• Females with FSH < 13 mIU/mL

• Sperm obtained via Surgical retrieval (any type) for IVF only

• Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy

• BMI < 35

• Baseline antral follicle count of > 8

• Single embryo transfers only

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)

• Fewer than 4 mature oocytes retrieved (will not randomize)

• Male partner with non-obstructive azoospermia

• Male partner with any Karyotype other than 46,XY

• Male partner with history of spinal cord injury

• Male partner with Kallman's syndrome

• History of chronic oligomenorrhea

• History of hydrosalpinges or adnexal mass

• History of endometrial insufficiency (max endometrial thickness < 7mm)

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Slow Freezing and Thawing
half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ben-Ami I, Raziel A, Strassburger D, Komarovsky D, Ron-El R, Friedler S. Intracytoplasmic sperm injection outcome of ejaculated versus extracted testicular spermatozoa in cryptozoospermic men. Fertil Steril. 2013 Jun;99(7):1867-71. doi: 10.1016/j.fertnstert.2013.02.025. Epub 2013 Mar 13. — View Citation

Cui X, Ding P, Gao G, Zhang Y. Comparison of the Clinical Outcomes of Intracytoplasmic Sperm Injection Between Spermatozoa Retrieved From Testicular Biopsy and From Ejaculate in Cryptozoospermia Patients. Urology. 2017 Apr;102:106-110. doi: 10.1016/j.urology.2016.08.071. Epub 2016 Nov 25. — View Citation

Forman EJ, Li X, Ferry KM, Scott K, Treff NR, Scott RT Jr. Oocyte vitrification does not increase the risk of embryonic aneuploidy or diminish the implantation potential of blastocysts created after intracytoplasmic sperm injection: a novel, paired randomized controlled trial using DNA fingerprinting. Fertil Steril. 2012 Sep;98(3):644-9. doi: 10.1016/j.fertnstert.2012.04.028. Epub 2012 May 17. — View Citation

Levine LA, Dimitriou RJ, Fakouri B. Testicular and epididymal percutaneous sperm aspiration in men with either obstructive or nonobstructive azoospermia. Urology. 2003 Aug;62(2):328-32. — View Citation

Ohlander S, Hotaling J, Kirshenbaum E, Niederberger C, Eisenberg ML. Impact of fresh versus cryopreserved testicular sperm upon intracytoplasmic sperm injection pregnancy outcomes in men with azoospermia due to spermatogenic dysfunction: a meta-analysis. Fertil Steril. 2014 Feb;101(2):344-9. doi: 10.1016/j.fertnstert.2013.10.012. Epub 2013 Dec 9. — View Citation

Pabuccu EG, Caglar GS, Tangal S, Haliloglu AH, Pabuccu R. Testicular versus ejaculated spermatozoa in ICSI cycles of normozoospermic men with high sperm DNA fragmentation and previous ART failures. Andrologia. 2017 Mar;49(2). doi: 10.1111/and.12609. Epub 2016 Apr 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastulation Rate	total number of embryos reaching the blastulation stage of development	5-7 days post ICSI procedure
Secondary	Fertilization Rate	number of 2PNs	1 day post ICSI
Secondary	Time to Find Sperm in Fresh Specimen	total amount of time spent finding sperm in the fresh surgical testicular sperm sample	up to 6 hours post surgery
Secondary	Post-thaw recovery rate of frozen surgical sperm	analysis of sperm parameters post freezing	30 minutes after freezing
Secondary	Aneuploidy Rate	number of chromosomally normal and abnormal embryos	2 weeks post trophectoderm biopsy
Secondary	Implantation Rate	presence of fetal heart beat at discharge to obstetric care	approximately 4-6 weeks post embryo transfer