Clinical trial NCT04724343: Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes.
Official title: Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on IVF/ICSI Outcomes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: In Vitro Fertilization
Intracytoplasmic Sperm Injection
Infertility
Keywords: GnRH Agonist
GnRH Antagonist
Assisted reproduction technique
In Vitro Fertilization
Intracytoplasmic sperm injection
Placental growth factor
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: 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.


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 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.

Primary outcomes:
measure: Follicular fluid Placental Growth Factor (PlGF) Concentrations:
timeFrame: Immediately after oocyte retrieval (35±2 hours after hCG administration)
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: 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:
citation: Lai Q, Zhang H, Zhu G, Li Y, Jin L, He L, Zhang Z, Yang P, Yu Q, Zhang S, Xu JF, Wang CY. Comparison of the GnRH agonist and antagonist protocol on the same patients in assisted reproduction during controlled ovarian stimulation cycles. Int J Clin Exp Pathol. 2013 Aug 15;6(9):1903-10. eCollection 2013.
citation: Hoseini FS, Noori Mugahi SM, Akbari-Asbagh F, Eftekhari-Yazdi P, Aflatoonian B, Aghaee-Bakhtiari SH, Aflatoonian R, Salsabili N. A randomized controlled trial of gonadotropin-releasing hormone agonist versus gonadotropin-releasing hormone antagonist in Iranian infertile couples: oocyte gene expression. Daru. 2014 Oct 7;22(1):67. doi: 10.1186/s40199-014-0067-4.
citation: Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4.
citation: Binder NK, Evans J, Salamonsen LA, Gardner DK, Kaitu'u-Lino TJ, Hannan NJ. Placental Growth Factor Is Secreted by the Human Endometrium and Has Potential Important Functions during Embryo Development and Implantation. PLoS One. 2016 Oct 6;11(10):e0163096. doi: 10.1371/journal.pone.0163096. eCollection 2016.
citation: Bender HR, Trau HA, Duffy DM. Placental Growth Factor Is Required for Ovulation, Luteinization, and Angiogenesis in Primate Ovulatory Follicles. Endocrinology. 2018 Feb 1;159(2):710-722. doi: 10.1210/en.2017-00739.
citation: Alpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.