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

Sponsor
Royan Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01009567
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
49
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2009
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Control

Receive human albumin 20% infusion

Drug: Control
Receive human albumin 20% infusion
Other Names:
  • 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 Names:
  • B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage and severity of OHSS in two groups [6 days after embryos transfer (ET)]

    Secondary Outcome Measures

    1. Efficacy and safety of cabergoline and albumin [6 days after embryos transfer (ET)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR Tehran Iran, Islamic Republic of 14114

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Royan Institute
    ClinicalTrials.gov Identifier:
    NCT01009567
    Other Study ID Numbers:
    • Royan-Emb-004
    First Posted:
    Nov 6, 2009
    Last Update Posted:
    May 6, 2015
    Last Verified:
    Nov 1, 2009
    Keywords provided by Royan Institute
    OHSS
    Additional relevant MeSH terms:
    Ovarian Hyperstimulation Syndrome
    Cabergoline

    Study Results

    No Results Posted as of May 6, 2015