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Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

This study has been completed.
Information provided by:
Royan Institute Identifier:
First received: November 13, 2009
Last updated: July 14, 2011
Last verified: November 2009
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.

Condition Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Methylprednisolone
Drug: Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Royan Institute:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 218
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Case
Administration of Methylprednisolone
Drug: Methylprednisolone
Administration of Methylprednisolone
Other Name: Case
Sham Comparator: Control Drug: Control
Normal salin injection

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Poly Cystic Ovarian Syndrome patients
  • Indication for IVF/ICSI and Long Protocol ovarian stimulation
  • Basal FSH≥10
  • Normal BMI (20-25)
  • physical health

Exclusion Criteria:

  • Allergy to GnRH analogues, FSH and corticosteroids
  • presence of heart failure, recent myocardial infarction
  • Hypertension
  • Diabetes mellitus
  • epilepsy
  • glaucoma
  • hypothyroidism
  • hepatic failure
  • osteoporosis
  • peptic ulceration
  • renal impairment
  • Using drugs that have interaction with corticosteroids such
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Please refer to this study by its identifier: NCT01014104

Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Royan Institute
Principal Investigator: Ashraf Moini, MD Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Principal Investigator: Marzieh Shiva, MD Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Principal Investigator: Narges bagheri lankarani, MD Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
  More Information

Additional Information:
Responsible Party: Hamid Gourabi, Chief, Royan Institute Identifier: NCT01014104     History of Changes
Other Study ID Numbers: Royan-Emb-005
Study First Received: November 13, 2009
Last Updated: July 14, 2011

Keywords provided by Royan Institute:
Ovarian hyper stimulation syndrome

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 24, 2017