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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014104

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT01014104     History of Changes
Other Study ID Numbers: Royan-Emb-005
Study First Received: November 13, 2009
Last Updated: July 14, 2011
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
Ovarian hyper stimulation syndrome
Methylprednisolone
IVF

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014