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Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cabergoline
Control
Sponsored by
Royan Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes
  • ovarian stimulation with long protocol

Exclusion Criteria:

  • coasting cases

Sites / Locations

  • Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Cabergoline

Arm Description

Receive human albumin 20% infusion

Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval

Outcomes

Primary Outcome Measures

Percentage and severity of OHSS in two groups

Secondary Outcome Measures

Efficacy and safety of cabergoline and albumin

Full Information

First Posted
November 5, 2009
Last Updated
May 5, 2015
Sponsor
Royan Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01009567
Brief Title
Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
Official Title
Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royan Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the efficacy and safety of cabergoline in prevention of ovarian hyperstimulation syndrome versus albumin in ART program.
Detailed Description
Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic potentially life threatening complication of assisted reproduction technologies due to gonadotropin and human chorionic gonadotropin administration. Its severe form has been reported in 1-10% of in vitro fertilization cycles. Different strategies have been proposed for the prevention of OHSS in high-risk patients, but these approaches do not offer complete protection against the development of ovarian hyperstimulation syndrome (OHSS). Among the selected preventive methods, discontinuing (coasting) gonadotropin therapy and i.v. albumin were by far the most popular choices. Several previous studies have shown that cabergoline is a safe drug, both for mother and conceptus, for the treatment of macroadenoma hyperprolactinemia. We think that this kind of therapy may be safe both for mother and conceptus (as previously shown by several studies on dopamine agonists treatment of hyperprolactinemia during pregnancy), easier, cheaper and probably, more effective than previous OHSS treatments (albumin, steroids, dopamine). There is an urgent need to test cabergoline efficacy in OHSS prevention in high risk patients with a large multicenter study. The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. Patients entering the intracytoplasmic sperm injection (ICSI) / IVF program in Royan institute and infertility research center in Valieasr hospital in Iran. We use a downregulation protocol with a GnRH agonist (buserelin acetate) as a long protocol for ICSI/ IVF-ET. We evaluate patients for high risk factors of severe OHSS. The inclusion criterion was the collection of >20 oocytes during oocyte retrieval. They allocate by a series of computer-generated random into two groups after the oocytes retrieval. 30 minutes after oocytes retrieval patients in A Group , receive human albumin 20% infusion and in B group receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval then women in all groups will informed about the signs and symptoms of OHSS and counsel to contact with our institute if OHSS develops. Patients will monitor routinely 6days after ET by ultrasonographic examination for ovarian size and for detection of ascites. Moderate to severe OHSS patients hospitalize and evaluate routinely by haematological and biochemical tests. OHSS patients diagnose and classify according to Golan et al 1989.we compare incidence of OHSS and severity of OHSS patients in two groups. Pregnant patients follow until the 12th gestational week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OHSS

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Receive human albumin 20% infusion
Arm Title
Cabergoline
Arm Type
Experimental
Arm Description
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Intervention Type
Drug
Intervention Name(s)
Cabergoline
Other Intervention Name(s)
B
Intervention Description
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Intervention Type
Drug
Intervention Name(s)
Control
Other Intervention Name(s)
A
Intervention Description
Receive human albumin 20% infusion
Primary Outcome Measure Information:
Title
Percentage and severity of OHSS in two groups
Time Frame
6 days after embryos transfer (ET)
Secondary Outcome Measure Information:
Title
Efficacy and safety of cabergoline and albumin
Time Frame
6 days after embryos transfer (ET)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients at risk of developing OHSS, defined by the development of 20-30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes ovarian stimulation with long protocol Exclusion Criteria: coasting cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eniseh Tehraninejad, MD
Organizational Affiliation
Royan Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ashraf Moini, MD
Organizational Affiliation
Board scientific
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marzieh Shiva, MD
Organizational Affiliation
scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22231013
Citation
Tehraninejad ES, Hafezi M, Arabipoor A, Aziminekoo E, Chehrazi M, Bahmanabadi A. Comparison of cabergoline and intravenous albumin in the prevention of ovarian hyperstimulation syndrome: a randomized clinical trial. J Assist Reprod Genet. 2012 Mar;29(3):259-64. doi: 10.1007/s10815-011-9708-4. Epub 2012 Jan 10.
Results Reference
derived
Links:
URL
http://www.Royaninstitute.org
Description
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Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program

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