Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Methylprednisolone
Control
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring Ovarian hyper stimulation syndrome, Methylprednisolone, IVF
Eligibility 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
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Case
Control
Arm Description
Administration of Methylprednisolone
Outcomes
Primary Outcome Measures
Occurrence rate of Ovarian hyper stimulation syndrome
Secondary Outcome Measures
Estradiol concentration in the day before hCG administration
Retrieved and injected oocytes number and quality
Achieved and transferred embryos number and quality
Implantation rate
Chemical and clinical pregnancy rate and cancelation rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01014104
Brief Title
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
Official Title
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
Ovarian hyper stimulation syndrome, Methylprednisolone, IVF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case
Arm Type
Experimental
Arm Description
Administration of Methylprednisolone
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Case
Intervention Description
Administration of Methylprednisolone
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Normal salin injection
Primary Outcome Measure Information:
Title
Occurrence rate of Ovarian hyper stimulation syndrome
Time Frame
Until 20 days after embryos transfer
Secondary Outcome Measure Information:
Title
Estradiol concentration in the day before hCG administration
Time Frame
Until 20 days after embryos transfer
Title
Retrieved and injected oocytes number and quality
Time Frame
Until 20 days after embryos transfer
Title
Achieved and transferred embryos number and quality
Time Frame
Until 20 days after embryos transfer
Title
Implantation rate
Time Frame
Until 20 days after embryos transfer
Title
Chemical and clinical pregnancy rate and cancelation rate
Time Frame
Until 20 days after embryos transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashraf Moini, MD
Organizational Affiliation
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marzieh Shiva, MD
Organizational Affiliation
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Narges bagheri lankarani, MD
Organizational Affiliation
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.royaninstitute.org
Description
Related Info
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Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
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