Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

NCT ID: NCT02290002

Last Updated: 2017-02-14

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

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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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).

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 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

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

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

Group Type ACTIVE_COMPARATOR

coasting

Intervention Type OTHER

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

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

coasting

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

Intervention Type OTHER

Other Intervention Names

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doxium

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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khalid abd aziz mohamed

OTHER

Sponsor Role lead

Responsible Party

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khalid abd aziz mohamed

lecturer of ob/gyn

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ahmed saad, MD

Role: STUDY_CHAIR

lecturer of ob/gyn

khalid mohamed, MD

Role: STUDY_DIRECTOR

lecturer of ob/gyn

Locations

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Benha univesity hospital

Banhā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ahmed-khalid 8

Identifier Type: -

Identifier Source: org_study_id

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