Ovarian Hyperstimulation Syndrome Using Calcium Infusion

NCT05198128 | Unknown

• 1 other identifier: 2217-2021
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSS; calcium infusion; IVF; ICSI

Outcome Measures

Primary Outcomes (1)

• OHSS rate

  ovarain hyperstimulation syndrome

  one year

Study Arms (2)

Calcium intravenous infusion

EXPERIMENTAL

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

saline

PLACEBO COMPARATOR

0.9 % saline intravenous infusion

Drug: 0.9 % saline

Interventions

Calcium intravenous infsuion DRUG

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

Calcium intravenous infusion

0.9 % saline DRUG

0.9 % saline

saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women undergoing Ovarian Hyperstimulation Syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR: ahmedsaidali, MCS CANDIDIATE

Model Details: Calcium for Prevention of Ovarian Hyperstimulation Syndrome (OHSS)

Study Record Dates

• First Submitted: December 19, 2021
• First Posted: January 20, 2022
• Study Start: March 1, 2022
• Primary Completion: April 25, 2023
• Study Completion: May 10, 2023
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share