Clinical trial NCT04724486: Effect of GnRH Agonist vs GnRH Antagonist on Oocyte Morphology During IVF/ICSI
Official title: Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology During IVF/ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: In Vitro Fertilization
Intracytoplasmic Sperm Injection
Infertility
Keywords: GnRH Agonist
GnRH Antagonist
Oocyte morphology
Assisted reproduction technique
In Vitro Fertilization
Intracytoplasmic sperm injection
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of oocyte dysmorphisms among the studied groups:
timeFrame: Before oocytes microinjection
Secondary outcomes:
measure: Number of oocytes retrieved:
timeFrame: Immediately after oocyte retrieval (35±2 hours after hCG administration)
measure: Number of Metaphase II Oocytes (MII):
timeFrame: Within two hours after oocyte retrieval
measure: Number of Metaphase I Oocytes (MI):
timeFrame: Within two hours after oocyte retrieval
measure: Number of Germinal Vesicle Oocytes (GV):
timeFrame: Within two hours after oocyte retrieval
measure: Number of Atretic Oocytes:
timeFrame: Within two hours after oocyte retrieval
measure: Maturation Rate%:
timeFrame: Within two hours after oocyte retrieval
measure: Fertilization Rate%:
timeFrame: 16-18 hours after microinjection
measure: Cleavage Rate%:
timeFrame: Day 2 after microinjection
measure: Embryo Quality:
timeFrame: Day of transfer (2 or 3 days after microinjection)
measure: High Quality Embryos rate%:
timeFrame: Day of transfer (2 or 3 days after microinjection)
measure: Biochemical Pregnancy Rate% (Per Embryo Transfer):
timeFrame: 2 weeks after embryo transfer
measure: Clinical Pregnancy Rate% (Per Embryo Transfer):
timeFrame: 3-4 weeks after embryo transfer
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Orient Hospital
Study officials:
affiliation: Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria
name: Sally Kadoura, B Pharm, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria
name: Abdul Hakim Nattouf, MD, PhD
role: STUDY_DIRECTOR
affiliation: Professor at Department of Embryology and Reproductive Medicine, Faculty of Medicine, Damascus University, Damascus, Syria.
name: Marwan Alhalabi, MD, PhD
role: STUDY_DIRECTOR
References:
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