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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Royan Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01009567
First received: November 5, 2009
Last updated: May 21, 2013
Last verified: November 2009
  Purpose

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 Intervention Phase
Ovarian Hyperstimulation Syndrome
Drug: Cabergoline
Drug: Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Percentage and severity of OHSS in two groups [ Time Frame: 6 days after embryos transfer (ET) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy and safety of cabergoline and albumin [ Time Frame: 6 days after embryos transfer (ET) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: June 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01009567

Contacts
Contact: Nasser Aghdami, MD (+98)2122339913 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)2122339951 leila.arab@yahoo.com

Locations
Iran, Islamic Republic of
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR Recruiting
Tehran, Iran, Islamic Republic of, 14114
Contact: Eniseh Tehraninejad, MD    +98 21 22305236    tehraninejad@royaninstitute.org   
Sub-Investigator: Arezoo Arabipoor, MSc         
Principal Investigator: Ladan Mohammadi Yeganeh, MSc         
Sub-Investigator: Nargess Bagheri Lankarani, PhD         
Sub-Investigator: Naimeh Mirghavam, BSc         
Sub-Investigator: Ali Reza Dabirsiaghi, PhD         
Sponsors and Collaborators
Royan Institute
Investigators
Study Director: Eniseh Tehraninejad, MD Royan Institute
Study Director: Ashraf Moini, MD Board scientific
Principal Investigator: Marzieh Shiva, MD scientist
  More Information

Additional Information:
No publications provided by Royan Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01009567     History of Changes
Other Study ID Numbers: Royan-Emb-004
Study First Received: November 5, 2009
Last Updated: May 21, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
OHSS

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Adnexal Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Albunex
Cabergoline
Anti-Dyskinesia Agents
Antineoplastic Agents
Antiparkinson Agents
Central Nervous System Agents
Contrast Media
Diagnostic Uses of Chemicals
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014