Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

Condition(s) targeted: Ovarian Hyperstimulation Syndrome

Intervention: Methylprednisolone (Drug); Control (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Royan Institute

Official(s) and/or principal investigator(s):
Ashraf Moini, MD, Principal Investigator, Affiliation: Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Marzieh Shiva, MD, Principal Investigator, Affiliation: Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Narges bagheri lankarani, MD, Principal Investigator, Affiliation: Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran

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.

Official title: Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Occurrence rate of Ovarian hyper stimulation syndrome

Secondary outcome:

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

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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

Royan Institute, Tehran 14114, Iran, Islamic Republic of

Starting date: October 2009
Last updated: July 14, 2011