Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

July 14, 2011 updated by: Royan Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Drug: Control
Normal salin injection
Experimental: Case
Administration of Methylprednisolone
Drug: Methylprednisolone
Administration of Methylprednisolone
Other Names:
  • Case

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence rate of Ovarian hyper stimulation syndrome
Time Frame: Until 20 days after embryos transfer
Until 20 days after embryos transfer

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royan Institute

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (Estimate)

November 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 15, 2011

Last Update Submitted That Met QC Criteria

July 14, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Royan-Emb-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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