Intracytoplasmic Sperm InjectionNCT03033563
ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa
An observational study of Intracytoplasmic Sperm Injection, run by Adam International Hospital.
Trial summary
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracytoplasmic Sperm Injection
- What is being tested?
- Intracytoplasmic sperm injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 31 Dec 2014
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Infertile couples
Who may be able to join
- Couples seeking ICSI.
Who cannot join
- Couples not seeking ICSI.
About this study
Official title: ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.
Read the detailed description
The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study.
First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm.
Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.
- Conditions
- Intracytoplasmic Sperm Injection
- Being tested
- Intracytoplasmic sperm injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracytoplasmic sperm injectionProcedure or surgery
Intracytoplasmic sperm injection
| Study group | Role | What they receive |
|---|---|---|
| Testicular tissue versus ejaculate | Evaluation of ICSI outcome. Receives: Procedure: Intracytoplasmic sperm injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracytoplasmic sperm injection outcome
Pregnancy rate.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 Jan 2012
- Primary completion1 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracytoplasmic Sperm InjectionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adam International Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Raef Sadek, Adam International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03033563
- Sponsor's protocol ID
- 2017
- Status last verified
- Jan 2017
- First submitted
- 21 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men
- ClinicalTrials.gov ID
- NCT03033563
- Acronym / sponsor ID
- 2017
- Conditions
- Intracytoplasmic Sperm Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Adam International HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 1 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 27 Jan 2017 (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.
The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.
Detailed description
The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study.
First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm.
Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Testicular tissue versus ejaculate | – | Procedure: Intracytoplasmic sperm injectionEvaluation of ICSI outcome. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile couples
Key inclusion criteria (1 listed)
- Couples seeking ICSI.
Key exclusion criteria (1 listed)
- Couples not seeking ICSI.
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 |
|---|---|---|
| Intracytoplasmic sperm injectionIntracytoplasmic sperm injection | Procedure or surgery | Testicular tissue versus ejaculate |
Primary outcome
Intracytoplasmic sperm injection outcome
Time frame: three years
Pregnancy rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracytoplasmic Sperm Injection, run by Adam International Hospital.
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 1 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: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intracytoplasmic sperm injection outcome (time frame: three years). 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 27 Jan 2017; AzTrials last refreshed its copy on 7 Nov 2026.