NCT03473613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Typical duration for phase_3

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

October 1, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.5 years

First QC Date

February 22, 2018

Last Update Submit

March 27, 2018

Conditions

Ovarian Hyperstimulation

Keywords

Calcium infusionCabergoline

Outcome Measures

Primary Outcomes (1)

  • Occurrence of ovarian hyperstimuation syndrome

    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 Outcomes (3)

  • Types of ovarian hyperstimuation syndrome and severity

    20 days from ovum pick up day

  • Chemical pregnancy

    14 day from embryos transfer day

  • Clinical pregnancy

    5 week from embryos transfer day

Study Arms (2)

Calcium infusion

ACTIVE COMPARATOR

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

Oral Cabergoline

ACTIVE COMPARATOR

Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily

Drug: Oral Cabergoline

Interventions

Oral CabergolineDRUG

Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days

Also known as: Cabergamon
Oral Cabergoline
Calcium GluconateDRUG

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

Also known as: Calcium
Calcium infusion

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen undergoing assisted reproductive technologies
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashraf nassif Elmantwe

Cairo, Elqalopia, 5131, Egypt

Location

MeSH Terms

Interventions

CabergolineCalcium GluconateCalcium

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingGluconatesSugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Ashraf N Elmantwe, MD

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 22, 2018

Study Start

October 1, 2014

Primary Completion

April 15, 2017

Study Completion

April 15, 2017

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Contact investigators

Locations

EG(1)