Clinical Trial: Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial

Brief Summary: 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.

Detailed Summary:

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 ac
Sponsor: Royan Institute

Current Primary Outcome: Occurrence rate of Ovarian hyper stimulation syndrome [ Time Frame: Until 20 days after embryos transfer ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Estradiol concentration in the day before hCG administration [ Time Frame: Until 20 days after embryos transfer ]
  • Retrieved and injected oocytes number and quality [ Time Frame: Until 20 days after embryos transfer ]
  • Achieved and transferred embryos number and quality [ Time Frame: Until 20 days after embryos transfer ]
  • Implantation rate [ Time Frame: Until 20 days after embryos transfer ]
  • Chemical and clinical pregnancy rate and cancelation rate [ Time Frame: Until 20 days after embryos transfer ]


Original Secondary Outcome: Same as current

Information By: Royan Institute

Dates:
Date Received: November 13, 2009
Date Started: October 2009
Date Completion:
Last Updated: July 14, 2011
Last Verified: November 2009