Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01014104
Other study ID # Royan-Emb-005
Secondary ID
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
See also
  Status Clinical Trial Phase
Withdrawn NCT00617864 - The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome N/A
Withdrawn NCT01979341 - The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes N/A
Completed NCT01427335 - Calcium for Prevention of Ovarian Hyperstimulation Syndrome Phase 3
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Completed NCT06333691 - Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin N/A
Terminated NCT01714648 - Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome? Phase 4
Completed NCT01500863 - Endometrial Receptivity After GnRH Agonist Triggering Phase 4
Recruiting NCT00417144 - Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients Phase 4
Completed NCT03876145 - The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome N/A
Completed NCT05588635 - Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Not yet recruiting NCT02392520 - Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) N/A
Completed NCT00835523 - Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist N/A
Completed NCT00665041 - Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome Phase 2
Active, not recruiting NCT05638529 - Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome Phase 4
Not yet recruiting NCT03071172 - Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET Phase 3
Recruiting NCT02084940 - Long Acting GnRH Antagonist in PCOS Women Undergoing IVF N/A
Completed NCT01815138 - Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS Phase 4
Completed NCT00867659 - The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors N/A
Completed NCT01569256 - Ovarian Hyperstimulation Syndrome and Cabergoline N/A
Not yet recruiting NCT05198128 - Ovarian Hyperstimulation Syndrome Using Calcium Infusion N/A

External Links