In Vitro Fertilization, Intracytoplasmic Sperm Injection, Infertility, Polycystic Ovary Syndrome
Conditions
Keywords
GnRH Agonist, GnRH Antagonist, Assisted reproduction technique, In Vitro Fertilization, Intracytoplasmic sperm injection, Polycystic Ovary Syndrome, Placental growth factor
Brief summary
This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation
Interventions
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.
DRUGCetrorelix
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 (hCG) when at least three follicles become more than 16-17 mm.
Sponsors
Damascus University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* PCOS women diagnosed according to the Rotterdam criteria 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicular fluid Placental Growth Factor (PlGF) Concentrations: | Immediately after oocyte retrieval (35±2 hours after hCG administration) | Follicular fluid samples will be obtained on the day of oocyte retrieval, then they will be centrifuged to eliminate cellular elements and debris. After that, the supernatants will be frozen at -80 until assayed using an Elisa kit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Metaphase II Oocytes (MII): | Within two hours after oocyte retrieval | The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope. |
| Maturation Rate%: | Within two hours after oocyte retrieval | Maturation Rate is calculated by dividing the number of mature (MII) oocytes by the number of retrieved oocytes. |
| Fertilization Rate%: | 16-18 hours after microinjection. | Fertilization Rate is calculated by dividing the number of obtained zygote (2PN) by the number of injected oocytes. |
| Cleavage Rate%: | Day 2 after microinjection. | Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN). |
| Number of oocytes retrieved | Immediately after oocyte retrieval (35±2 hours after hCG administration) | The oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration 35±2 hours after hCG administration. |
| High Quality Embryos rate%: | Day of transfer (2 or 3 days after microinjection). | High Quality Embryos rate is calculated by dividing the number of high quality embryos (Grade I) by the total number of cleavaged embryos. |
| Biochemical Pregnancy Rate% (Per Embryo Transfer): | 2 weeks after 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. |
| Clinical Pregnancy Rate% (Per Embryo Transfer): | 3-4 weeks after 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. |
| Embryo Quality: | Day of transfer (2 or 3 days after microinjection). | Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011). |
Countries
Syria
Outcome results
None listed