Compare the Efficacy of Human Albumin With Cabergoline to Prevent Ovarian Hyper Stimulation in Assisted Reproductive Technology (ART) Program
Information source: Royan Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Hyperstimulation Syndrome
Intervention: Cabergoline (Drug); Control (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Royan Institute Official(s) and/or principal investigator(s): Eniseh Tehraninejad, MD, Study Director, Affiliation: Royan Institute Ashraf Moini, MD, Study Director, Affiliation: Board scientific Marzieh Shiva, MD, Principal Investigator, Affiliation: scientist
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.
Clinical Details
Official title: Compare the Efficacy of Human Albumin With Cabergoline to Prevent of Ovarian Hyper Stimulation in ART Program
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Percentage and severity of OHSS in two groups
Secondary outcome: Efficacy and safety of cabergoline and albumin
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
Minimum age: 25 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran 14114, Iran, Islamic Republic of
Additional Information
Starting date: June 2009
Last updated: May 5, 2015
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