DRUG
Triptorelin acetate
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.
Status
Completed
Phase
Phase 4
Enrollment
50
Locations
1
Results
Not posted
Publications
6
Study summary
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 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
DRUG
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.
DRUG
0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
DRUG
Dosage adjustment according to the ovarian response.
DRUG
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.
Timeline
First posted
Jan 26, 2021
Study start
Dec 22, 2019
Primary completion
Jan 1, 2022
Study completion
Jul 5, 2022
Results posted
Not reported
Registry updated
Oct 24, 2023
Outcomes
Follicular fluid Placental Growth Factor (PlGF) Concentrations:
Time frame · 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 Eliza kit.
Number of oocytes retrieved:
Time frame · 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.
Number of Metaphase II Oocytes (MII):
Time frame · Within two hours after oocyte retrieval
The oocyte maturity will be assessed using Nikon SMZ1500 stereoscope.
Maturation Rate%:
Time frame · 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%:
Time frame · 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%:
Time frame · Day 2 after microinjection
Cleavage rate is calculated by dividing the number of cleavaged embryos by the number of zygotes (2PN).
Embryo Quality:
Time frame · Day of transfer (2 or 3 days after microinjection)
Embryos are assessed using Nikon SMZ1500 stereoscope based on ESHRE criteria (2011).
High Quality Embryos rate%:
Time frame · 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):
Time frame · 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):
Time frame · 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.
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 ovary 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.
Study locations
Syria. Showing up to 24 locations stored in the fast local snapshot.
Orient Hospital
Damascus, Syria
Publications
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