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Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

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ClinicalTrials.gov Identifier: NCT02290002
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : February 14, 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 versus costing 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 Other: coasting 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 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done

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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 Coasting for Prevention of Ovarian Hyperstimulation Syndrome
Study Start Date : June 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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
In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
Other: coasting
In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done




Primary Outcome Measures :
  1. Number of participants with ovarian hyperstimulation syndrome (OHSS) [ Time Frame: every two weeks 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



Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:

    • Presence of more than 20 follicles by ultrasound
    • E2 more than 3000 pg/ml
    • Retrieval of more than 15 follicles

Exclusion Criteria:

  • None

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): NCT02290002


Locations
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Egypt
Benha univesity hospital
Benha, Egypt, 13518
Sponsors and Collaborators
khalid abd aziz mohamed
Investigators
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Study Chair: ahmed saad, MD lecturer of ob/gyn
Study Director: khalid mohamed, MD lecturer of ob/gyn
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Responsible Party: khalid abd aziz mohamed, lecturer of ob/gyn, Benha University
ClinicalTrials.gov Identifier: NCT02290002    
Other Study ID Numbers: ahmed-khalid 8
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Infertility
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Calcium Dobesilate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Hemostatics
Coagulants