ICSI, IVF, Normal Responders, Infertility Assisted Reproductive Technology, Infertile Women Undergoing IVF or ICSI, Infertile Women Undergoing ART, Triggering Ovulation, Oocyte Maturation
Conditions
Keywords
icsi, ivf, dual trigger, hcg trigger, infertility, ART, normal responders, oocyte maturation
Brief summary
To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles.
Detailed description
To compare the embryological and reproductive outcomes of dual trigger versus conventional hCG trigger for final oocyte maturation in normal responder patients undergoing ICSI cycles. * Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG. * hCG Trigger Group: Participants will receive hCG alone. primary Outcomes The following primary outcomes will be assessed: • Number of mature (MII) oocytes (assessment at denudation). Secondary Outcomes The following secondary outcomes will be assessed: * Number of retrieved oocytes. * Fertilization rate. * Number and quality of embryos. * Implantation rate. * Clinical pregnancy rate. * Multiple pregnancy rate. * Incidence of ovarian hyperstimulation syndrome (OHSS).
Interventions
Dual Trigger Group: Participants will receive a GnRH agonist combined with hCG for normal responders patients doing ICSI.
DRUGhCG trigger
hCG Trigger Group: Participants will receive hCG alone the standard for normal responders doing ICSI.
Sponsors
Al-Azhar University
International Islamic Center for Population Studies and Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Clinical Trial comparing two parallel groups receiving different ovulation triggering options during ICSI cycle
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 20-40 years. * Body mass index (BMI) between 18 and 30 kg/m². * Undergoing ICSI treatment using a GnRH antagonist protocol. * Normal ovarian reserve and expected normal ovarian response. * AMH between 1.2 - 3.5 ng/ml * AFC 7-15 follicle. * First or second ICSI cycle.
Exclusion criteria
* Poor ovarian response (Bologna/POSEIDON criteria) * High ovarian response with a risk of ovarian hyperstimulation syndrome (OHSS) AMH \> 3.5 ng/ml or AFC \> 15 follicle. * Polycystic ovary syndrome (PCOS). * Serum E2 level \> 3500 pg/ml at day of triggering. * Endocrine disorders including diabetes mellitus, thyroid dysfunction, hyperprolactinemia, congenital adrenal hyperplasia, or Cushing syndrome. * Congenital uterine abnormalities. * Severe systemic diseases affecting fertility outcomes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oocytes Maturation | From oocyte retrieval until completion of oocyte assessment, approximately 0-2 hours after retrieval. | Percentage of retrieved oocytes that are at the metaphase II (MII) stage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes | At oocyte retrieval (Day 0), approximately 0-2 hours after oocyte pick up. | Number of metaphase II oocytes retrieved |
| Number of oocytes retrieved | Day of oocyte retrieval (Day 0) after oocyte retrieval. | Total number of oocytes retrieved during oocyte retrieval. |
| Fertilization rate | Approximately 16-18 hours after insemination/ICSI | Percentage of normally fertilized mature oocytes (2PN) |
| Embryo utilization rate | Day 3-5 after oocyte retrieval | Percentage of normally fertilized oocytes resulting in embryos suitable for transfer or cryopreservation |
| Clinical pregnancy rate | Approximately 5-7 weeks after embryo transfer | Percentage of embryo transfer cycles resulting in an intrauterine gestational sac with fetal cardiac activity |
| Incidence of ovarian hyperstimulation syndrome (OHSS) | From the day of trigger administration until 14 days after oocyte retrieval | Proportion of participants developing OHSS following controlled ovarian stimulation and oocyte retrieval, classified according to predefined diagnostic/severity criteria. |
Countries
Egypt
Contacts
CONTACTAhmed MM Gebreel, MSc
STUDY_DIRECTOREhab HM Hasanin, Professor
Obstetrics and Gynecology Department, Al-Azhar University.
STUDY_DIRECTORMohamed S. Abdelall, Professor
International Islamic Center for Population Studies and Research
Outcome results
None listed