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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First Ejaculate for ICSI | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | periprocedural |
| semen analysis |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | The clinical pregnancy rate will be assessed by detecting pregnancy via ultrasound after embryo transfer. This will help assess the long-term outcome of fertilization with sperm from the first and second ejaculates. | up to 6 weeks |
| Sperm DNA Fragmentation index (DFI) |
Inclusion Criteria:
Exclusion Criteria:
Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis.
- Male partners who need testicular biopsy to retrieve sperms.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nour El-Hayat Fertility Center | Cairo | Cairo Governorate | 11762 | Egypt |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D020554 | Sperm Injections, Intracytoplasmic |
| ID | Term |
|---|---|
| D005307 | Fertilization in Vitro |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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|
| Second Ejaculate for ICSI | Procedure | 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 |
|
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. |
| Baseline |
Sperm DNA fragmentation will be assessed using the HALO test (sperm chromatin dispersion assay), following the manufacturer's protocol. The DNA fragmentation index (DFI) will be calculated as the percentage of sperm cells showing fragmented DNA. |
| Baseline |
| D052801 |
| Male Urogenital Diseases |
| D008919 | Investigative Techniques |