NCT02271360

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 16, 2017

Status Verified

February 1, 2017

Enrollment Period

1.7 years

First QC Date

October 19, 2014

Last Update Submit

February 14, 2017

Conditions

Infertility

Keywords

infertility ICSI OHSS Calcium Dobesilate Cabergoline

Outcome Measures

Primary Outcomes (1)

  • Number of participants with ovarian hyperstimulation syndrome (OHSS)

    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

    weekly for eight weeks

Secondary Outcomes (1)

  • pregnancy rate

    14 days after embryos transfer

Study Arms (2)

group A

ACTIVE COMPARATOR

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

group B

ACTIVE COMPARATOR

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

Interventions

Calcium DobesilateDRUG

1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days

Also known as: doxium
group A
CabergolineDRUG

1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days

Also known as: Dostinex
group B

Eligibility Criteria

Age22 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha univesity hospital

Banhā, El Qualyobia, 13518, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

Calcium DobesilateCabergoline

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

BenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur CompoundsErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • khalid mohamed, MD

    lecturer of ob/gyn

    STUDY CHAIR

  • ahmed saad, MD

    lecturer of ob/gyn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of ob/gyn

Study Record Dates

First Submitted

October 19, 2014

First Posted

October 22, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 16, 2017

Record last verified: 2017-02

Locations

EG(1)