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Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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ClinicalTrials.gov Identifier: NCT02271360
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
khalid abd aziz mohamed, Benha University

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Infertility Drug: Calcium Dobesilate Drug: Cabergoline Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome
Actual Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Infertility

Arm Intervention/treatment
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.
Drug: Calcium Dobesilate
1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
Other Name: doxium

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 .
Drug: Cabergoline
1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
Other Name: Dostinex




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. pregnancy rate [ Time Frame: 14 days after embryos transfer ]
    β-hCG (serum hCG test) will be checked 14 days after embryos transfer



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Ages Eligible for Study:   22 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271360


Locations
Egypt
Benha univesity hospital
Benha, El Qualyobia, Egypt, 13518
Sponsors and Collaborators
Benha University
Investigators
Study Chair: khalid mohamed, MD lecturer of ob/gyn
Principal Investigator: ahmed saad, MD lecturer of ob/gyn

Responsible Party: khalid abd aziz mohamed, lecturer of ob/gyn, Benha University
ClinicalTrials.gov Identifier: NCT02271360     History of Changes
Other Study ID Numbers: khalid-ahmed 7
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017

Keywords provided by khalid abd aziz mohamed, Benha University:
infertility ICSI OHSS Calcium Dobesilate Cabergoline

Additional relevant MeSH terms:
Infertility
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Calcium, Dietary
Cabergoline
Calcium Dobesilate
Bone Density Conservation Agents
Physiological Effects of Drugs
Antineoplastic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants