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 in polycystic ovary syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during IVF/ICSI.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
Dosage adjustment according to the ovarian response.
Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.
Orient Hospital
Damascus, Syria
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.
Time frame: Before oocytes microinjection
Number of oocytes retrieved:
The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration.
Time frame: Immediately after oocyte retrieval (35±2 hours after hCG administration)
Number of Metaphase II Oocytes (MII):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Time frame: Within two hours after oocyte retrieval
Number of Metaphase I Oocytes (MI):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Time frame: Within two hours after oocyte retrieval
Number of Germinal Vesicle Oocytes (GV):
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Time frame: Within two hours after oocyte retrieval
Number of Atretic Oocytes:
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Time frame: Within two hours after oocyte retrieval
Maturation Rate%:
Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes.
Time frame: Within two hours after oocyte retrieval
Fertilization Rate%:
Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes.
Time frame: 16-18 hours after microinjection
Cleavage Rate%:
Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).
Time frame: Day 2 after microinjection
Embryo Quality:
Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).
Time frame: Day of transfer (2 or 3 days after microinjection)
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.
Time frame: Day of transfer (2 or 3 days after microinjection)
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.
Time frame: 2 weeks after embryo transfer
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.
Time frame: 3-4 weeks after embryo transfer
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