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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01009567
Recruitment Status : Completed
First Posted : November 6, 2009
Last Update Posted : May 6, 2015
Information provided by (Responsible Party):
Royan Institute

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.

Condition or disease Intervention/treatment Phase
Ovarian Hyperstimulation Syndrome Drug: Cabergoline Drug: Control Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program
Study Start Date : June 2009
Primary Completion Date : June 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Sham Comparator: Control
Receive human albumin 20% infusion
Drug: Control
Receive human albumin 20% infusion
Other Name: A
Experimental: Cabergoline
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Drug: Cabergoline
Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
Other Name: B

Primary Outcome Measures :
  1. Percentage and severity of OHSS in two groups [ Time Frame: 6 days after embryos transfer (ET) ]

Secondary Outcome Measures :
  1. Efficacy and safety of cabergoline and albumin [ Time Frame: 6 days after embryos transfer (ET) ]

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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01009567

Iran, Islamic Republic of
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR
Tehran, Iran, Islamic Republic of, 14114
Sponsors and Collaborators
Royan Institute
Study Director: Eniseh Tehraninejad, MD Royan Institute
Study Director: Ashraf Moini, MD Board scientific
Principal Investigator: Marzieh Shiva, MD scientist

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Royan Institute Identifier: NCT01009567     History of Changes
Other Study ID Numbers: Royan-Emb-004
First Posted: November 6, 2009    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: November 2009

Keywords provided by Royan Institute:

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs