Fresh Vs Frozen Surgical Sperm in IVF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-25

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fresh surgical testicular sperm

Fresh, surgically obtained testicular sperm

Group Type NO_INTERVENTION

No interventions assigned to this group

Frozen surgical testicular sperm

Surgically obtained testicular sperm that will undergo slow freezing and thawing

Group Type EXPERIMENTAL

Slow Freezing and Thawing

Intervention Type OTHER

half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI

Interventions

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Slow Freezing and Thawing

half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI

Intervention Type OTHER

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No