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Fresh Vs Frozen Surgical Sperm in IVF

Primary Purpose

Infertility

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Slow Freezing and Thawing
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Reproductive Medicine Associates of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Fresh surgical testicular sperm

Frozen surgical testicular sperm

Arm Description

Fresh, surgically obtained testicular sperm

Surgically obtained testicular sperm that will undergo slow freezing and thawing

Outcomes

Primary Outcome Measures

Blastulation Rate
total number of embryos reaching the blastulation stage of development

Secondary Outcome Measures

Fertilization Rate
number of 2PNs
Time to Find Sperm in Fresh Specimen
total amount of time spent finding sperm in the fresh surgical testicular sperm sample
Post-thaw recovery rate of frozen surgical sperm
analysis of sperm parameters post freezing
Aneuploidy Rate
number of chromosomally normal and abnormal embryos
Implantation Rate
presence of fetal heart beat at discharge to obstetric care

Full Information

First Posted
November 29, 2017
Last Updated
January 13, 2022
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03361982
Brief Title
Fresh Vs Frozen Surgical Sperm in IVF
Official Title
Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
recruitment issues
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fresh surgical testicular sperm
Arm Type
No Intervention
Arm Description
Fresh, surgically obtained testicular sperm
Arm Title
Frozen surgical testicular sperm
Arm Type
Experimental
Arm Description
Surgically obtained testicular sperm that will undergo slow freezing and thawing
Intervention Type
Other
Intervention Name(s)
Slow Freezing and Thawing
Intervention Description
half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI
Primary Outcome Measure Information:
Title
Blastulation Rate
Description
total number of embryos reaching the blastulation stage of development
Time Frame
5-7 days post ICSI procedure
Secondary Outcome Measure Information:
Title
Fertilization Rate
Description
number of 2PNs
Time Frame
1 day post ICSI
Title
Time to Find Sperm in Fresh Specimen
Description
total amount of time spent finding sperm in the fresh surgical testicular sperm sample
Time Frame
up to 6 hours post surgery
Title
Post-thaw recovery rate of frozen surgical sperm
Description
analysis of sperm parameters post freezing
Time Frame
30 minutes after freezing
Title
Aneuploidy Rate
Description
number of chromosomally normal and abnormal embryos
Time Frame
2 weeks post trophectoderm biopsy
Title
Implantation Rate
Description
presence of fetal heart beat at discharge to obstetric care
Time Frame
approximately 4-6 weeks post embryo transfer

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Tiegs, MD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12893345
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. doi: 10.1016/s0090-4295(03)00374-1.
Results Reference
background
PubMed Identifier
27894976
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.
Results Reference
background
PubMed Identifier
23490166
Citation
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.
Results Reference
background
PubMed Identifier
27108915
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.
Results Reference
background
PubMed Identifier
24345355
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.
Results Reference
background
PubMed Identifier
22608316
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.
Results Reference
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Fresh Vs Frozen Surgical Sperm in IVF

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