Fresh Vs Frozen Surgical Sperm in IVF

Not Applicable

Terminated

• Conditions: Infertility
• Interventions: Other: Slow Freezing and Thawing

• Registration Number: NCT03361982
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Study Start: 2019-10-25
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Frozen surgical testicular sperm	Slow Freezing and Thawing	Surgically obtained testicular sperm that will undergo slow freezing and thawing

Primary Outcome Measures

Name	Time	Method
Blastulation Rate	5-7 days post ICSI procedure	total number of embryos reaching the blastulation stage of development

Secondary Outcome Measures

Name	Time	Method
Fertilization Rate	1 day post ICSI	number of 2PNs
Time to Find Sperm in Fresh Specimen	up to 6 hours post surgery	total amount of time spent finding sperm in the fresh surgical testicular sperm sample
Post-thaw recovery rate of frozen surgical sperm	30 minutes after freezing	analysis of sperm parameters post freezing
Aneuploidy Rate	2 weeks post trophectoderm biopsy	number of chromosomally normal and abnormal embryos
Implantation Rate	approximately 4-6 weeks post embryo transfer	presence of fetal heart beat at discharge to obstetric care

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States