Infertility Clinical Trial
Official title:
Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology During IVF/ICSI
Verified date | October 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology, especially with the limited and conflicted currently available data. Thus, we are conducting this prospective, non-randomised, open-label, clinical trial to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology during IVF/ICSI.
Status | Completed |
Enrollment | 50 |
Est. completion date | July 15, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility | Inclusion Criteria: - Women undergoing IVF/ICSI. - Age: 18-39 years. - Both ovaries present. Exclusion Criteria: - Age = 40 years - History of three or more previous IVF failures. - Patients with hormonal disorders like hyperprolactinemia, thyroid disorders. - Patients with Polycystic Ovarian Syndrome. - Patients who previously undergo Unilateral Oophorectomy. - Patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases. - Patients with diseases may affect IVF outcomes: Endometriosis, uterine fibroids, Hydrosalpinx, Adenomyosis, autoimmune diseases, - Cancer. |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Orient Hospital | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of oocyte dysmorphisms among the studied groups: | Before being subjected to ICSI, the oocytes from both groups will be morphologically analyzed under an inverted microscope; Nikon Eclipse Ti2; in order to detect cytoplasmic and extra-cytoplasmic dysmorphisms. | Before oocytes microinjection | |
Secondary | Number of oocytes retrieved: | The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration. | Immediately after oocyte retrieval (35±2 hours after hCG administration) | |
Secondary | Number of Metaphase II Oocytes (MII): | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope. | Within two hours after oocyte retrieval | |
Secondary | Number of Metaphase I Oocytes (MI): | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope. | Within two hours after oocyte retrieval | |
Secondary | Number of Germinal Vesicle Oocytes (GV): | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope. | Within two hours after oocyte retrieval | |
Secondary | Number of Atretic Oocytes: | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope. | Within two hours after oocyte retrieval | |
Secondary | Maturation Rate%: | Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes. | Within two hours after oocyte retrieval | |
Secondary | Fertilization Rate%: | Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes. | 16-18 hours after microinjection | |
Secondary | Cleavage Rate%: | Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN). | Day 2 after microinjection | |
Secondary | Embryo Quality: | Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011). | Day of transfer (2 or 3 days after microinjection) | |
Secondary | High Quality Embryos rate%: | High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos. | Day of transfer (2 or 3 days after microinjection) | |
Secondary | Biochemical Pregnancy Rate% (Per Embryo Transfer): | Biochemical pregnancy is defined as a positive serum beta-hCG pregnancy test after 2 weeks of embryo transfer. The biochemical pregnancy rate is calculated by dividing the number of women who are biochemically pregnant by the number of women who have at least 1 embryo transferred. | 2 weeks after embryo transfer | |
Secondary | Clinical Pregnancy Rate% (Per Embryo Transfer): | Clinical pregnancy is defined as the presence of a gestational sac on ultrasound after 3-4 weeks of embryo transfer. The clinical pregnancy rate is calculated as by dividing the number of women who are clinically pregnant divided by the number of women who have at least 1 embryo transferred. | 3-4 weeks after embryo transfer |
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