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CompletedNCT01009567Updated May 6, 2015

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

A Phase 1/2 interventional study of Cabergoline and Control in Ovarian Hyperstimulation Syndrome, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by Royan Institute · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Ovarian Hyperstimulation Syndrome

Keywords

  • OHSS
03

In context

Ovarian Hyperstimulation Syndrome

64 studies on the registry are indexed under Ovarian Hyperstimulation Syndrome; 3 are open to participants now.

This study's planned enrollment of 10 is below the median of 100 across 48 interventional studies indexed under Ovarian Hyperstimulation Syndrome.

Browse Ovarian Hyperstimulation Syndrome studies →

Lead sponsor

Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
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

Exclusion Criteria:

  • coasting cases
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Sham comparator
    Control

    Receive human albumin 20% infusion

    Drug: Control

  • Experimental
    Cabergoline

    Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval

    Drug: Cabergoline

Interventions

  • DrugCabergoline

    Receive cabergoline tablet (0/5 mg) daily until 6 days after oocytes retrieval

    Also known as: B

  • DrugControl

    Receive human albumin 20% infusion

    Also known as: A

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What researchers measure

Primary outcomes

  1. Percentage and severity of OHSS in two groups

    Time frame: 6 days after embryos transfer (ET)

Secondary outcomes

  1. Efficacy and safety of cabergoline and albumin

    Time frame: 6 days after embryos transfer (ET)

07

Study locations

1 site
  • Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR
    Tehran, 14114, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 22231013 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01009567
Lead sponsor
Royan Institute
Responsible party
Sponsor
First posted
Nov 6, 2009
Start date
Jun 2009
Primary completion
Jun 2013
Completion
Jul 2013
Last update
May 6, 2015

Study contacts

Eniseh Tehraninejad, MD
study director · Royan Institute
Ashraf Moini, MD
study director · Board scientific
Marzieh Shiva, MD
principal investigator · scientist

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.

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