Male InfertilityNCT07056400
Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles
A study testing First Ejaculate for ICSI and Second Ejaculate for ICSI in people with Male Infertility, run by Ain Shams University at 1 site in Egypt.
Trial summary
The Aim of the trial: Assess if a consecutive second ejaculate contains an equal, or even higher number of motile sperm and produces high-quality sperm for intracytoplasmic sperm injection (ICSI) in male factor patients and if it will improve clinical outcomes, such as fertilization rate, embryo quality, number of… Read more about this study
- Who is it for?
- Ages 25 to 45 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- First Ejaculate for ICSI and Second Ejaculate for ICSI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male: with abnormal semen parameter according to WHO.
- Age range between 25-45 for both partners.
Who cannot join
- Female with factors that might affect Oocyte quality:
- Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.
- Male partners who need testicular biopsy to retrieve sperms.
Trial locations and contacts
1 site in 1 country.
About this study
The Aim of the trial:
Assess if a consecutive second ejaculate contains an equal, or even higher number of motile sperm and produces high-quality sperm for intracytoplasmic sperm injection (ICSI) in male factor patients and if it will improve clinical outcomes, such as fertilization rate, embryo quality, number of blastocysts retrieved per cycle, implantation, and hopefully pregnancy rates.
Read the detailed description
Background:
According to research, the length of abstinence has an impact on sperm DNA fragmentation (SDF) as well as sperm parameters. Long abstinence period increases the volume of semen and the concentration of sperm, but it will negatively impact motility, viability, and morphology.
The second ejaculation of males shows a considerable improvement in total motility and a significant decrease in (SDF) when it is collected within 1 to 3 hours of the first ejaculate.
it is essential to ensure the availability of high-quality spermatozoa with second ejaculation to enhance clinical results in ICSI cycles
- Conditions
- Male Infertility
- Being tested
- First Ejaculate for ICSI, Second Ejaculate for ICSI
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Ejaculate for ICSIProcedure or surgery
Intervention 1: First Ejaculate for ICSI In this intervention, sperm collected from the first ejaculate will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used in fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the first ejaculate
Second Ejaculate for ICSIProcedure or surgery
In this intervention, sperm collected from the second ejaculate (obtained within 1-2 hours after the first ejaculate) will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used for fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the second ejaculate and its impact on fertilization rates and embryo development
| Study group | Role | What they receive |
|---|---|---|
| first ejaculate | Experimental | In this arm, participants will undergo ICSI using sperm collected from the first ejaculate. Semen analysis will be conducted to assess sperm quality, including motility, morphology, and concentration. This arm will serve as the baseline for comparison with the second ejaculate arm. Receives: Procedure: First Ejaculate for ICSI |
| Second Ejaculate | Experimental | Participants in this arm will undergo ICSI using sperm collected from the second ejaculate, which will be obtained within a short interval (1-2 hours) after the first. Semen analysis will be conducted to compare sperm quality with that of the first ejaculate, and fertilization and embryo development outcomes will be evaluated Receives: Procedure: Second Ejaculate for ICSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
fertilization rate.
Fertilization will be confirmed after 16-18 hours by the observation of two distinct pronuclei (2PN) and two polar bodies. The fertilization rate will be calculated as the number of fertilized oocytes divided by total number of mature oocytes (MII) for each couple. Oocytes with 2PN will be observed
Measured: Periprocedural
Secondary outcomes (2)
Embryo development rate
Oocytes with 2PN will be observed for embryonic development on day 2 and 3 until day 5 after micro-injection. The embryo development rates will be calculated as the number of embryos developed divided by the total number of mature oocytes for each couple.
Measured: periprocedural
semen analysis
Semen samples will be analyzed in both the first and second ejaculate according to the World Health Organization (WHO) 2021 guidelines. The following parameters will be assessed:
Semen volume (mL) Sperm concentration (million/mL) Total sperm count (million) Progressive motility (%) Total motility (%) Normal morphology (%) Analysis will be performed in a certified andrology laboratory using standardized techniques.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start3 Apr 2024
- Primary completion1 Dec 2025
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056400
- Sponsor's protocol ID
- Sci1312408001
- Status last verified
- Apr 2025
- First submitted
- 15 Jun 2025
- Last updated
- 5 Jan 2026
- Results posted
- 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 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Improve Fertilization Rate and Embryo Development in Intracytoplasmic Sperm Injection (ICSI) Cycles
- ClinicalTrials.gov ID
- NCT07056400
- Acronym / sponsor ID
- Sci1312408001
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 9 Jul 2025 (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 Aim of the trial:
Assess if a consecutive second ejaculate contains an equal, or even higher number of motile sperm and produces high-quality sperm for intracytoplasmic sperm injection (ICSI) in male factor patients and if it will improve clinical outcomes, such as fertilization rate, embryo quality, number of blastocysts retrieved per cycle, implantation, and hopefully pregnancy rates.
Detailed description
Background:
According to research, the length of abstinence has an impact on sperm DNA fragmentation (SDF) as well as sperm parameters. Long abstinence period increases the volume of semen and the concentration of sperm, but it will negatively impact motility, viability, and morphology.
The second ejaculation of males shows a considerable improvement in total motility and a significant decrease in (SDF) when it is collected within 1 to 3 hours of the first ejaculate.
it is essential to ensure the availability of high-quality spermatozoa with second ejaculation to enhance clinical results in ICSI cycles
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first ejaculate | Experimental | Procedure: First Ejaculate for ICSIIn this arm, participants will undergo ICSI using sperm collected from the first ejaculate. Semen analysis will be conducted to assess sperm quality, including motility, morphology, and concentration. This arm will serve as the baseline for comparison with the second ejaculate arm. |
| Second Ejaculate | Experimental | Procedure: Second Ejaculate for ICSIParticipants in this arm will undergo ICSI using sperm collected from the second ejaculate, which will be obtained within a short interval (1-2 hours) after the first. Semen analysis will be conducted to compare sperm quality with that of the first ejaculate, and fertilization and embryo development outcomes will be evaluated |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male: with abnormal semen parameter according to WHO.
- Age range between 25-45 for both partners.
Key exclusion criteria (3 listed)
- Female with factors that might affect Oocyte quality:
- Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.
- Male partners who need testicular biopsy to retrieve sperms.
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 |
|---|---|---|
| First Ejaculate for ICSIIntervention 1: First Ejaculate for ICSI In this intervention, sperm collected from the first ejaculate will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used in fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the first ejaculate | Procedure or surgery | first ejaculate |
| Second Ejaculate for ICSIIn this intervention, sperm collected from the second ejaculate (obtained within 1-2 hours after the first ejaculate) will be used in Intracytoplasmic Sperm Injection (ICSI). The sperm will be analyzed for motility, morphology, and concentration before being used for fertilization and embryo culture. This arm will evaluate the quality of sperm obtained from the second ejaculate and its impact on fertilization rates and embryo development | Procedure or surgery | Second Ejaculate |
Primary outcome
fertilization rate.
Time frame: Periprocedural
Fertilization will be confirmed after 16-18 hours by the observation of two distinct pronuclei (2PN) and two polar bodies. The fertilization rate will be calculated as the number of fertilized oocytes divided by total number of mature oocytes (MII) for each couple. Oocytes with 2PN will be observed
2 secondary outcomes
Embryo development rate
Time frame: periprocedural
semen analysis
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Ejaculate for ICSI and Second Ejaculate for ICSI in people with Male Infertility, run by Ain Shams 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
fertilization rate. (time frame: Periprocedural). 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 5 Jan 2026.