Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

Royan Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ovarian Hyperstimulation Syndrome

Treatments: Drug: Control; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01014104

Royan-Emb-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

Case

Experimental group

Description:

Administration of Methylprednisolone

Treatment:

Drug: Methylprednisolone

Control

Sham Comparator group

Treatment:

Drug: Control