Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

NCT ID: NCT02271360

Last Updated: 2017-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Calcium Dobesilate

Intervention Type DRUG

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

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 .

Group Type ACTIVE_COMPARATOR

Cabergoline

Intervention Type DRUG

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

Interventions

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Calcium Dobesilate

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

Intervention Type DRUG

Cabergoline

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

Intervention Type DRUG

Other Intervention Names

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doxium Dostinex

Eligibility Criteria

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Exclusion Criteria

* None
Minimum Eligible Age

22 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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khalid abd aziz mohamed

lecturer of ob/gyn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khalid mohamed, MD

Role: STUDY_CHAIR

lecturer of ob/gyn

ahmed saad, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer of ob/gyn

Locations

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Benha univesity hospital

Banhā, El Qualyobia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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khalid-ahmed 7

Identifier Type: -

Identifier Source: org_study_id

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