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Ovarian Hyperstimulation Syndrome Using Calcium Infusion

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Calcium intravenous infsuion
0.9 % saline
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS, calcium infusion, IVF, ICSI

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

- infertile women aged 20 to 38 years. BMI ranged from 18 to 40. serum FSH within normal limits( 1-12IU /l) presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion Criteria:

  • endocrinopathies. a systemic disease. and Insulin-dependent diabetes Thyroid disease using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists. patients need coasting for high risk of OHSS. patients need cycle cancellation. severe male infertility requiring testicular sperm extraction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Calcium intravenous infusion

    saline

    Arm Description

    intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group. Intravenous infusion was performed within 30 minutes

    0.9 % saline intravenous infusion

    Outcomes

    Primary Outcome Measures

    OHSS rate
    ovarain hyperstimulation syndrome

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2021
    Last Updated
    February 20, 2022
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05198128
    Brief Title
    Ovarian Hyperstimulation Syndrome Using Calcium Infusion
    Official Title
    Ovarian Hyper Stimulation Syndrome Using Calcium Infusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2022 (Anticipated)
    Primary Completion Date
    April 25, 2023 (Anticipated)
    Study Completion Date
    May 10, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART
    Detailed Description
    Among assisted reproductive technologies (ART), ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication affects up to 30% of women undergoing ART and caries high risks of morbidity and mortality. Women with age younger than 35 years, those with history of polycystic ovary syndrome (PCOS), or having a history of previous OHSS are more susceptible to develop OHSS

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Hyperstimulation Syndrome
    Keywords
    OHSS, calcium infusion, IVF, ICSI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Calcium intravenous infusion
    Arm Type
    Experimental
    Arm Description
    intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group. Intravenous infusion was performed within 30 minutes
    Arm Title
    saline
    Arm Type
    Placebo Comparator
    Arm Description
    0.9 % saline intravenous infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium intravenous infsuion
    Intervention Description
    intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group. Intravenous infusion was performed within 30 minutes
    Intervention Type
    Drug
    Intervention Name(s)
    0.9 % saline
    Intervention Description
    0.9 % saline
    Primary Outcome Measure Information:
    Title
    OHSS rate
    Description
    ovarain hyperstimulation syndrome
    Time Frame
    one year

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    women undergoing Ovarian Hyperstimulation Syndrome
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - infertile women aged 20 to 38 years. BMI ranged from 18 to 40. serum FSH within normal limits( 1-12IU /l) presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration. Exclusion Criteria: endocrinopathies. a systemic disease. and Insulin-dependent diabetes Thyroid disease using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists. patients need coasting for high risk of OHSS. patients need cycle cancellation. severe male infertility requiring testicular sperm extraction.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    not yet

    Learn more about this trial

    Ovarian Hyperstimulation Syndrome Using Calcium Infusion

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