ICSI AZOOSPERMIA VARICOCELENCT02306499
Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia
A study testing ICSI in people with ICSI AZOOSPERMIA VARICOCELE, run by Sohag University at 1 site in Egypt.
Trial summary
This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ICSI AZOOSPERMIA VARICOCELE
- What is being tested?
- ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Dec 2015
- 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
- cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in aى ART program.
- ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.
Who cannot join
- Cases with known female factor infertility
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ajyal Hospital
Sohag
Ramadan Saleh, MD, 01005423054, salehr2010@yahoo.com
About this study
This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.
Read the detailed description
Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University.
This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag .
Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.
Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded.
Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.
- Conditions
- ICSI AZOOSPERMIA VARICOCELE
- Being tested
- ICSI
- Keywords
- VARICOCELE-AZOOSPERMIA-ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSIProcedure or surgery
Intracytoplasmic Sperm Injection
| Study group | Role | What they receive |
|---|---|---|
| ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE | Experimental | ICSI cases using cryopreserved testicular sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program Receives: Procedure: ICSI |
| ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE | Experimental | ICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele Receives: Procedure: ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.
Measured: 6/2014 up to one year.
Secondary outcomes (3)
Fertilization Rate: percentage of fertilized oocyte.
Measured: 6/2014 up to one year.
Embryo Quality: morphological assessment of the developing embryo.
Measured: 6/2014 up to one year.
Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.
Measured: 6/2014 up to one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICSI AZOOSPERMIA VARICOCELEStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Al-Hussini Jad Abdel-latif, M.B.B.Ch., Sohag University
- Investigators
- Ramadan Saleh, MD, Study director, Sohag UniversityReham Ezz-Eldawla, MD, Study director, Sohag UniversityMohamed Yahya, MD, Study director, Sohag UniversityMuhammed Fawzy, Study director, Ibn Sina Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306499
- Sponsor's protocol ID
- 729/2014
- Other IDs
- 729/259/2014
- Status last verified
- Nov 2014
- First submitted
- 22 Nov 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia
- ClinicalTrials.gov ID
- NCT02306499
- Acronym / sponsor ID
- 729/2014
- Conditions
- ICSI AZOOSPERMIA VARICOCELE
- Keywords
- VARICOCELE-AZOOSPERMIA-ICSI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Dec 2014 (estimated)
- 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.
This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.
Detailed description
Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University.
This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag .
Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.
Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded.
Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE | Experimental | Procedure: ICSIICSI cases using cryopreserved testicular sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program |
| ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE | Experimental | Procedure: ICSIICSI cases using cryopreserved testicular sperms from infertile azoospermic men due to etiologies other than varicocele |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in aى ART program.
- ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.
Key exclusion criteria (1 listed)
- Cases with known female factor infertility
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 |
|---|---|---|
| ICSIIntracytoplasmic Sperm Injection | Procedure or surgery | ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH NO VARICOCELE, ICSI WITH CRYOPRESERVED SPERM FROM NOA WITH VARICOCELE |
Primary outcome
Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.
Time frame: 6/2014 up to one year.
3 secondary outcomes
Fertilization Rate: percentage of fertilized oocyte.
Time frame: 6/2014 up to one year.
Embryo Quality: morphological assessment of the developing embryo.
Time frame: 6/2014 up to one year.
Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.
Time frame: 6/2014 up to one year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
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.
Ramadan Saleh, MD study director
Sohag University
Reham Ezz-Eldawla, MD study director
Sohag University
Mohamed Yahya, MD study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI in people with ICSI AZOOSPERMIA VARICOCELE, run by Sohag University at 1 site in Egypt.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Dec 2014. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Alhussini, M.B.B.Ch. (00201005817574, drhussini@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment. (time frame: 6/2014 up to one year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2014.