InfertilityNCT03361982
Fresh Vs Frozen Surgical Sperm in IVF
A study testing Slow Freezing and Thawing in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility
- What is being tested?
- Slow Freezing and Thawing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Slow Freezing and Thawing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow Freezing and ThawingOther
half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI
| Study group | Role | What they receive |
|---|---|---|
| Fresh surgical testicular sperm | No intervention | Fresh, surgically obtained testicular sperm |
| Frozen surgical testicular sperm | Experimental | Surgically obtained testicular sperm that will undergo slow freezing and thawing Receives: Other: Slow Freezing and Thawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastulation Rate
total number of embryos reaching the blastulation stage of development
Measured: 5-7 days post ICSI procedure
Secondary outcomes (5)
Fertilization Rate
number of 2PNs
Measured: 1 day post ICSI
Time to Find Sperm in Fresh Specimen
total amount of time spent finding sperm in the fresh surgical testicular sperm sample
Measured: up to 6 hours post surgery
Post-thaw recovery rate of frozen surgical sperm
analysis of sperm parameters post freezing
Measured: 30 minutes after freezing
Aneuploidy Rate
number of chromosomally normal and abnormal embryos
Measured: 2 weeks post trophectoderm biopsy
Implantation Rate
presence of fetal heart beat at discharge to obstetric care
Measured: approximately 4-6 weeks post embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start25 Oct 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: recruitment issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashley Tiegs, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361982
- Sponsor's protocol ID
- RMA-2017-06
- Status last verified
- Jan 2022
- First submitted
- 29 Nov 2017
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12893345Cui 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.
PubMed 27894976Ben-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.
PubMed 23490166Pabuccu 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.
PubMed 27108915Ohlander 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.
PubMed 24345355Forman 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.
PubMed 22608316
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
- ClinicalTrials.gov ID
- NCT03361982
- Acronym / sponsor ID
- RMA-2017-06
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment issues
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh surgical testicular sperm | No intervention | –Fresh, surgically obtained testicular sperm |
| Frozen surgical testicular sperm | Experimental | Other: Slow Freezing and ThawingSurgically obtained testicular sperm that will undergo slow freezing and thawing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Slow Freezing and Thawinghalf of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI | Other | Frozen surgical testicular sperm |
Primary outcome
Blastulation Rate
Time frame: 5-7 days post ICSI procedure
total number of embryos reaching the blastulation stage of development
5 secondary outcomes
Fertilization Rate
Time frame: 1 day post ICSI
Time to Find Sperm in Fresh Specimen
Time frame: up to 6 hours post surgery
Post-thaw recovery rate of frozen surgical sperm
Time frame: 30 minutes after freezing
Aneuploidy Rate
Time frame: 2 weeks post trophectoderm biopsy
Implantation Rate
Time frame: approximately 4-6 weeks post embryo transfer
Results and safety
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Background: PubMed 12893345Levine 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.
- Background: PubMed 27894976Cui 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.
- Background: PubMed 23490166Ben-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.
- Background: PubMed 27108915Pabuccu 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.
- Background: PubMed 24345355Ohlander 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.
- Background: PubMed 22608316Forman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Tiegs, MD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow Freezing and Thawing in people with Infertility, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastulation Rate (time frame: 5-7 days post ICSI procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03361982, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.