Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014104
• Other study ID #: Royan-Emb-005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 13, 2009
• Last updated: July 14, 2011
• Start date: October 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Royan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics CommitteeIran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• Syndrome

Intervention

Drug:
• Methylprednisolone
Administration of Methylprednisolone
• Control
Normal salin injection

Locations

Country	Name	City	State
Iran, Islamic Republic of	Royan Institute	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Royan Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence rate of Ovarian hyper stimulation syndrome		Until 20 days after embryos transfer	Yes
Secondary	Estradiol concentration in the day before hCG administration		Until 20 days after embryos transfer	Yes
Secondary	Retrieved and injected oocytes number and quality		Until 20 days after embryos transfer	Yes
Secondary	Achieved and transferred embryos number and quality		Until 20 days after embryos transfer	No
Secondary	Implantation rate		Until 20 days after embryos transfer	No
Secondary	Chemical and clinical pregnancy rate and cancelation rate		Until 20 days after embryos transfer	Yes

External Links

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