About this trial
This prospective observational study will include women undergoing IVF treatment with a GnRH antagonist protocol and fresh embryo transfer at the IVF unit of Shaare Zedek Medical Center. Patients will undergo controlled ovarian stimulation followed by ovulation triggering with hCG, GnRH agonist, or dual trigger according to OHSS risk. After oocyte retrieval and fertilization by IVF/ICSI, embryos will be cultured and transferred. Luteal phase support will consist of either intranasal GnRH agonist (Synarel) or vaginal progesterone. Blood and follicular fluid samples will be collected at predefined time points to assess hormonal, inflammatory, and angiogenic markers, including LH, FSH, estradiol, progesterone, IL-6, IL-8, VEGF, PEDF, and relaxin.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women included in the study will be 18-45 years old
undergoing IVF treatments due to ovulation disorder, mechanical factor, primary ovarian insufficiency, or male infertility.
All women will be at their first to the third cycle of treatment
women will undergo a fresh ET.
Disqualifiers
repeated implantation failure (more than 3 cycles of good quality ET without implantation)
moderate-severe endometriosis
hydrosalpinx
fibroid uterus
Trial population
women undergoing IVF treatment with OPU and ET
Trial design
Case-control
Prospective
Treatments tested in this trial
GnRH agonist
Drugspray of 200 mcg Nafarelin (Synarel) twice a day for two weeks
Progesterone
DrugPV progesterone administered until hCG day and continued for 8-10
Treatment groups
Trial outcomes
Primary outcomes
Positive pregnancy rate
serum βhCG ≥ 25 IU/L, measured 14 days after ET.
Secondary outcomes
Level of blood markers along the luteal phase
LH, FSH (secreted from pituitary gland), steroid hormones, cytokines, and other proteins secreted from CL (Estradiol, Progesterone, Relaxin, IL-6, IL-8)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Heli Alexandroni
Lead sponsor
Shaare Zedek Medical Center
Sponsor institution