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

November 5, 2009
May 21, 2013
June 2009
June 2013   (final data collection date for primary outcome measure)
Percentage and severity of OHSS in two groups [ Time Frame: 6 days after embryos transfer (ET) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01009567 on ClinicalTrials.gov Archive Site
Efficacy and safety of cabergoline and albumin [ Time Frame: 6 days after embryos transfer (ET) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Ovarian Hyperstimulation Syndrome
  • Drug: Cabergoline
    Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
    Other Name: B
  • Drug: Control
    Receive human albumin 20% infusion
    Other Name: A
  • Sham Comparator: Control
    Receive human albumin 20% infusion
    Intervention: Drug: Control
  • Experimental: Cabergoline
    Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval
    Intervention: Drug: Cabergoline
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
July 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
25 Years to 45 Years
No
Contact: Nasser Aghdami, MD (+98)2122339913 nasser.aghdami@royaninstitute.org
Contact: Leila Arab, MD (+98)2122339951 leila.arab@yahoo.com
Iran, Islamic Republic of
 
NCT01009567
Royan-Emb-004
Yes
Royan Institute
Royan Institute
Not Provided
Study Director: Eniseh Tehraninejad, MD Royan Institute
Study Director: Ashraf Moini, MD Board scientific
Principal Investigator: Marzieh Shiva, MD scientist
Royan Institute
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP