Ovarian Hyperstimulation Syndrome Clinical Trial
Official title:
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.
Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation
which might be life threatening in the severe forms. Since there is still no definite cure
for this syndrome, prevention is considered as an essential and vital issue. The objective
of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper
stimulation syndrome in IVF cycles.
The study population comprises all infertile patients with diagnosis of polycystic ovarian
syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized
based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea,
hyper androgynism (clinical or laboratory), LH/FSH>2 and ovarian morphological evidences in
Doppler ultrasound.
The existence of more than 20 follicles in both ovaries and E2 concentration >4000 pg/ml
will be considered as the OHSS risk factors.
In this study all eligible patients will be randomly allocated into two study groups by a
computerized randomization method:
Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the
first day of stimulation and will be tapered after the first pregnancy test (day 13 after
the embryo transfer). Furthermore, these patients will receive a bolus IV dose
methylprednisolone, 1g on the day of egg collection and embryo transfer.
Patients in the control group will not receive any treatment with glucocorticoids. If each
group confronts with every kind of high risk signs or symptoms, they will undergo coasting
or gonadotropin withdrawal or other treatment strategies.
The presence of OHSS is defined in accordance with the Golan 5 grade system and women who at
least are at grade 2 of this classification (Mild) considered as OHSS cases and will
experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and
enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be
observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing
disorders, hemoconcentration, coagulopathy and renal perfusion decrease.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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