Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome

Overview

The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.

Full Title of Study: “Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 2015

Detailed Description

Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of assisted reproduction. Complications of OHSS include vascular thrombosis, pulmonary embolism, renal failure, electrolyte disturbances, ascites, hydrothorax ,torsion of the ovary, abortion or rarely death. Previous studies revealed that converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS. The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.

Interventions

  • Drug: Cabergoline
    • Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.
  • Drug: GnRH antagonist rescue & cabergoline
    • when the leading follicle reaches 16 mm, HP-uFSH is continued at daily dose of 75 IU/day till the day of HCG administration. Moreover, Gn RH agonist (triptorelin) is discontinued and GnRH antagonist (Cetrorelix acetate)0.25 mg S.C is administered daily till the day of HCG administration. Serum estradiol is measured daily and HCG (5,000 IU/I.M) is administered when serum estradiol level drops below 3500 pg/ml . Moreover, cabergoline 0.5 mg p.o is administered at bed time for 8 days starting on the day of HCG administration.

Arms, Groups and Cohorts

  • Active Comparator: Cabergoline group
    • Cabergoline is administered starting on the day of HCG administration.
  • Experimental: GnRH antagonist rescue & cabergoline group
    • Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration.

Clinical Trial Outcome Measures

Primary Measures

  • Moderate or severe ovarian hyperstimulation syndrome
    • Time Frame: Within 4 weeks of HCG adminstration

Secondary Measures

  • The Number of Participants Who Achieved Ongoing Pregnancy
    • Time Frame: 18 weeks after embryo transfer

Participating in This Clinical Trial

Inclusion Criteria

  • Patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol and at high risk of developing OHSS [ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml] Exclusion Criteria:

  • Fibrosis of lung, – swelling or inflammation around the heart or lung, – hypertension, – liver disease, – heart valve disease and – allergy to cabergoline or ergot derivatives.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aljazeera Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof .Usama M.Fouda, M.D , PhD – Aljazeera Hospital
  • Overall Official(s)
    • Usama M Fouda, M.D,PhD, Study Chair, Aljazeera (Al Gazeera) hospital
  • Overall Contact(s)
    • Usama M Fouda, M.D,PhD, 01095401375, umfrfouda@yahoo.com

References

Aboulghar MA, Mansour RT, Amin YM, Al-Inany HG, Aboulghar MM, Serour GI. A prospective randomized study comparing coasting with GnRH antagonist administration in patients at risk for severe OHSS. Reprod Biomed Online. 2007 Sep;15(3):271-9.

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