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NCT05198128 Clinical Trial

Ovarian Hyperstimulation Syndrome Using Calcium Infusion

Ovarian Hyperstimulation Syndrome Clinical Trial

Official title:
Ovarian Hyper Stimulation Syndrome Using Calcium Infusion

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05198128
Other study ID # 2217-2021
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date May 10, 2023

Study information
Verified date February 2022
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date May 10, 2023
Est. primary completion date April 25, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Ovarian Hyperstimulation Syndrome
  • Syndrome

Intervention

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
• 0.9 % saline
0.9 % saline

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Al-Azhar University

Outcome
Type Measure Description Time frame Safety issue
Primary OHSS rate ovarain hyperstimulation syndrome one year
See also
  Status Clinical Trial Phase
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Withdrawn NCT01979341 - The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes N/A
Completed NCT01427335 - Calcium for Prevention of Ovarian Hyperstimulation Syndrome Phase 3
Completed NCT01014104 - Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome Phase 1/Phase 2
Recruiting NCT00119925 - 'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists" N/A
Completed NCT06333691 - Comparative Study Between Calcium Gluconate With Diosmin, Cabergoline and Cabergoline With Diosmin N/A
Terminated NCT01714648 - Can GnRH Agonist Trigger Prevent Ovarian Hyperstimulation Syndrome? Phase 4
Completed NCT01500863 - Endometrial Receptivity After GnRH Agonist Triggering Phase 4
Recruiting NCT00417144 - Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients Phase 4
Completed NCT03876145 - The Four Methods of Ovarian Stimulation in Patients With Polycystic Ovarian Syndrome N/A
Completed NCT05588635 - Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Not yet recruiting NCT02392520 - Luteal Antagonist Versus Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) N/A
Completed NCT00835523 - Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist N/A
Completed NCT00665041 - Tolerability of Quinagolide in a Dose-titration Regimen in Oocyte Donors at Risk of Developing Ovarian Hyperstimulation Syndrome Phase 2
Active, not recruiting NCT05638529 - Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome Phase 4
Not yet recruiting NCT03071172 - Clinical Study of Recombinant Human Follitropin for Injection Assisted in COH Assisted IVF-ET Phase 3
Recruiting NCT02084940 - Long Acting GnRH Antagonist in PCOS Women Undergoing IVF N/A
Completed NCT01815138 - Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS Phase 4
Completed NCT00867659 - The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors N/A
Completed NCT01569256 - Ovarian Hyperstimulation Syndrome and Cabergoline N/A