Ovarian Hyperstimulation Syndrome Using Calcium Infusion

February 20, 2022 updated by: Ahmed Said Ali, Al-Azhar University

Ovarian Hyper Stimulation Syndrome Using Calcium Infusion

the incidence of OHSS and clinical outcomes after calcium IV infusion in high-risk women undergoing ART

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

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:

- 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium intravenous infusion

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
Drug: Calcium intravenous infsuion

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
Placebo Comparator: saline
0.9 % saline intravenous infusion
Drug: 0.9 % saline
0.9 % saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHSS rate
Time Frame: one year
ovarain hyperstimulation syndrome
one year

Collaborators and Investigators

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

Sponsor

Al-Azhar 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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

April 25, 2023

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

December 19, 2021

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 20, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2217-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

not yet

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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