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Fresh Vs Frozen Surgical Sperm in IVF

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ClinicalTrials.gov Identifier: NCT03361982
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : March 26, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Infertility Other: Slow Freezing and Thawing Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
No Intervention: Fresh surgical testicular sperm
Fresh, surgically obtained testicular sperm
Experimental: Frozen surgical testicular sperm
Surgically obtained testicular sperm that will undergo slow freezing and thawing
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




Primary Outcome Measures :
  1. Blastulation Rate [ Time Frame: 5-7 days post ICSI procedure ]
    total number of embryos reaching the blastulation stage of development


Secondary Outcome Measures :
  1. Fertilization Rate [ Time Frame: 1 day post ICSI ]
    number of 2PNs

  2. Time to Find Sperm in Fresh Specimen [ Time Frame: up to 6 hours post surgery ]
    total amount of time spent finding sperm in the fresh surgical testicular sperm sample

  3. Post-thaw recovery rate of frozen surgical sperm [ Time Frame: 30 minutes after freezing ]
    analysis of sperm parameters post freezing

  4. Aneuploidy Rate [ Time Frame: 2 weeks post trophectoderm biopsy ]
    number of chromosomally normal and abnormal embryos

  5. Implantation Rate [ Time Frame: approximately 4-6 weeks post embryo transfer ]
    presence of fetal heart beat at discharge to obstetric care



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361982


Contacts
Contact: Christine V Whitehead, BSN, RN 973-656-2841 clinicalresearchteam@rmanj.com
Contact: Talia Metzgar, RN 973-656-2841 clinicalresearchteam@rmanj.com

Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Ashley Tiegs, MD Reproductive Medicine Associates of New Jersey
Principal Investigator: James Hotaling, MD Reproductive Medicine Associates of New Jersey

Publications:

Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT03361982     History of Changes
Other Study ID Numbers: RMA-2017-06
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female