Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Overview

The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2015

Detailed Description

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days.

Interventions

  • Drug: Calcium Dobesilate
    • 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
  • Drug: Cabergoline
    • 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days

Arms, Groups and Cohorts

  • Active Comparator: group A
    • In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.
  • Active Comparator: group B
    • while in group B (Cabergoline group), 1 tab/day Cabergoline(Dostinex)( 0.5 mg) will be givenat day of HCG injection and for 8 days .

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with ovarian hyperstimulation syndrome (OHSS)
    • Time Frame: weekly for eight weeks
    • this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia

Secondary Measures

  • pregnancy rate
    • Time Frame: 14 days after embryos transfer
    • β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Participating in This Clinical Trial

Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., > 24 antral follicles present on baseline ultrasound examination), high AMH (> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 >3000 pg/ml or rapidly rising s.E2), presence of > 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (> 20). Exclusion Criteria:

  • None

Gender Eligibility: Female

Minimum Age: 22 Years

Maximum Age: 44 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Benha University
  • Provider of Information About this Clinical Study
    • Principal Investigator: khalid abd aziz mohamed, lecturer of ob/gyn – Benha University
  • Overall Official(s)
    • khalid mohamed, MD, Study Chair, lecturer of ob/gyn
    • ahmed saad, MD, Principal Investigator, lecturer of ob/gyn

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