Male Infertility
Conditions
Brief 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 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
Interventions
PROCEDUREFirst Ejaculate for ICSI
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
PROCEDURESecond Ejaculate for ICSI
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Male: with abnormal semen parameter according to WHO. * Age range between 25-45 for both partners.
Exclusion criteria
* Female with factors that might affect Oocyte quality: Polycystic ovary (PCO). Poor ovarian reserve. Endometriosis. \- Male partners who need testicular biopsy to retrieve sperms.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| fertilization rate. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Embryo development rate | periprocedural | 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. |
| semen analysis | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | up to 6 weeks | 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. |
| Sperm DNA Fragmentation index (DFI) | 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. |
Countries
Egypt
Outcome results
None listed