Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

March 27, 2018 updated by: ashraf nassif mahmoud elmantwe,MD, Benha University

Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial

Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elqalopia
      • Cairo, Elqalopia, Egypt, 5131
        • Ashraf nassif Elmantwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin

Exclusion Criteria:women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Calcium infusion
10ml 10%calcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days
Drug: Calcium Gluconate
Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days
Other Names:
  • Calcium
ACTIVE_COMPARATOR: Oral Cabergoline
Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily
Drug: Oral Cabergoline
Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days
Other Names:
  • Cabergamon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of ovarian hyperstimuation syndrome
Time Frame: 20 days from ovum pick up day
Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration
20 days from ovum pick up day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Types of ovarian hyperstimuation syndrome and severity
Time Frame: 20 days from ovum pick up day
Clinical severity either mild ,moderate or severe and its type either early or late onst
20 days from ovum pick up day
Chemical pregnancy
Time Frame: 14 day from embryos transfer day
Positive human chorionic Gonadotropin in blood
14 day from embryos transfer day
Clinical pregnancy
Time Frame: 5 week from embryos transfer day
Intrauterine gestational sac
5 week from embryos transfer day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

April 15, 2017

Study Completion (ACTUAL)

April 15, 2017

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (ACTUAL)

March 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 27, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ashraf Elmantwe 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Contact investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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