Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.

Damascus University

Status and phase: Completed; Phase 4

Conditions: In Vitro Fertilization; Infertility; Intracytoplasmic Sperm Injection

Treatments: Drug: Triptorelin acetate; Drug: Cetrorelix; Drug: Human Chorionic Gonadotropin (hCG); Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT04724343

Ph-CT-4299

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Agonist Group (Long protocol):

Active Comparator group

Description:

The pituitary down-regulation in this group will be carried out using 0.05-0.1 mg of Triptorelin acetate subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the menstrual cycle until the ovulation triggering day. When the suppressive effect is obtained, ovarian stimulation will commence with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) and the dose will be adjusted 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. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

Treatment:

Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Drug: Triptorelin acetate

Drug: Human Chorionic Gonadotropin (hCG)

Antagonist Group (Flexible protocol):

Experimental group

Description:

The ovarian stimulation in this group will be started with recombinant Follicle-Stimulating Hormone (r-FSH) or r-FSH + human Menopausal Gonadotropin (hMG) on the third day of the menstrual cycle and the dose will be adjusted according to the ovarian response. Initiation of 0.25 mg of GnRH antagonist; Cetrorelix; will take place after detecting a leading follicle diameter ≥ 14 mm. GnRH antagonist administration will be continued till the day of ovulation triggering, which will be accomplished by given 10,000 IU of human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm. After 35±2 hours of ovulation triggering, the oocytes will be retrieved by transvaginal ultrasound-guided follicle aspiration. Then they will be prepared to undergo an Intracytoplasmic Sperm Injection (ICSI).

Treatment:

Drug: recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Drug: Human Chorionic Gonadotropin (hCG)

Drug: Cetrorelix