Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Sponsor
Benha University (Other)
Overall Status
Completed
CT.gov ID
NCT03473613
Collaborator
(none)
230
1
2
30.5
7.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral Cabergoline
  • Drug: Calcium Gluconate
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
230 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Apr 15, 2017
Actual Study Completion Date :
Apr 15, 2017

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Occurrence of ovarian hyperstimuation syndrome [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

    Secondary Outcome Measures

    1. Types of ovarian hyperstimuation syndrome and severity [20 days from ovum pick up day]

      Clinical severity either mild ,moderate or severe and its type either early or late onst

    2. Chemical pregnancy [14 day from embryos transfer day]

      Positive human chorionic Gonadotropin in blood

    3. Clinical pregnancy [5 week from embryos transfer day]

      Intrauterine gestational sac

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ashraf nassif Elmantwe Cairo Elqalopia Egypt 5131

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Ashraf N Elmantwe, MD, Benha University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ashraf nassif mahmoud elmantwe,MD, Assistant professor, Benha University
    ClinicalTrials.gov Identifier:
    NCT03473613
    Other Study ID Numbers:
    • Ashraf Elmantwe 1
    First Posted:
    Mar 22, 2018
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ashraf nassif mahmoud elmantwe,MD, Assistant professor, Benha University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2018