Fresh Vs Frozen Surgical Sperm in IVF

Reproductive Medicine Associates of New Jersey

Status: Terminated

Conditions: Infertility

Treatments: Other: Slow Freezing and Thawing

Study type: Interventional

Funder types: Other

Identifiers

NCT03361982

RMA-2017-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups

Fresh surgical testicular sperm

No Intervention group

Description:

Fresh, surgically obtained testicular sperm

Frozen surgical testicular sperm

Experimental group

Description:

Surgically obtained testicular sperm that will undergo slow freezing and thawing

Treatment:

Other: Slow Freezing and Thawing