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Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT01014104
First received: November 13, 2009
Last updated: July 14, 2011
Last verified: November 2009

November 13, 2009
July 14, 2011
October 2009
August 2010   (final data collection date for primary outcome measure)
Occurrence rate of Ovarian hyper stimulation syndrome [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01014104 on ClinicalTrials.gov Archive Site
  • Estradiol concentration in the day before hCG administration [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: Yes ]
  • Retrieved and injected oocytes number and quality [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: Yes ]
  • Achieved and transferred embryos number and quality [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: No ]
  • Chemical and clinical pregnancy rate and cancelation rate [ Time Frame: Until 20 days after embryos transfer ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Ovarian Hyperstimulation Syndrome
  • Drug: Methylprednisolone
    Administration of Methylprednisolone
    Other Name: Case
  • Drug: Control
    Normal salin injection
  • Experimental: Case
    Administration of Methylprednisolone
    Intervention: Drug: Methylprednisolone
  • Sham Comparator: Control
    Intervention: Drug: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
218
December 2010
August 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01014104
Royan-Emb-005
Yes
Hamid Gourabi, Chief, Royan Institute
Royan Institute
Not Provided
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
Royan Institute
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP