Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
|ClinicalTrials.gov Identifier: NCT01014104|
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : July 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Hyperstimulation Syndrome||Drug: Methylprednisolone Drug: Control||Phase 1 Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial|
|Study Start Date :||October 2009|
|Primary Completion Date :||August 2010|
|Study Completion Date :||December 2010|
Administration of Methylprednisolone
Administration of Methylprednisolone
Other Name: Case
|Sham Comparator: Control||
Normal salin injection
- Occurrence rate of Ovarian hyper stimulation syndrome [ Time Frame: Until 20 days after embryos transfer ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014104
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of, 14114|
|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|