Evaluation of oral calcium effect versus placebo in the prevention of moderate to severe OHSS (ovarian hyperstimulation syndrome) in the high-risk patients for OHSS
Comparison between oral calcium and placebo in preventing of moderate to severe OHSS in patients at risk of OHSS (ovarian hyperstimulation syndrome)
Design
A clinical trial with a control group, based on the society, with the parallel group, one-sided blinded, randomized with 150 patients from September 2017 to September 2018.
Settings and conduct
This is a prospective study which was done in Mirza Kochakkhan hospital in Tehran. This study was designed as randomized single blinded (patients were blind and had no information about the intervention group)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Antagonist protocol for ART (Assisted Reproductive Technology) 2- The number of follicles ≥ 20 mm is over 20. 3- The plasma estradiol level ≥ 2500pg/ml
Exclusion criteria: 1-Patients with endocrine disease. 2- Patients with the systemic disease 3- History of neoplasm. 4- Patients that had the high level of plasma estradiol (≥6000pg/ml). 5- Use of insulin-sensitizing drugs. 6- Patients that were required to cycle cancellation
Intervention groups
1- Intervention group: Patients with moderate to severe Ovarian Hyperstimulation Syndrome (OHSS) that received Calcium Carbonate 500mg orally every 12 hours for 5 days after injection of HCG or recombinant HCG
2- Placebo group: Patients with moderate to severe OHSS that received oral placebo orally every 12 hours for 5 days after injection of HCG or recombinant HCG
Main outcome variables
1- prevalence mild OHSS between two groups( oral calcium and placebo)
2-prevalence moderate OHSS between two groups( oral calcium and placebo)
3-prevalence sever OHSS between two groups( oral calcium and placebo)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033490N2
Registration date:2018-12-05, 1397/09/14
Registration timing:retrospective
Last update:2018-12-05, 1397/09/14
Update count:0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Zahra Dehbashi
Name of organization / entity
Tehran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8608 9076
Email address
zdehbashi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-12, 1396/06/21
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of oral calcium effect versus placebo in the prevention of moderate to severe OHSS (ovarian hyperstimulation syndrome) in the high-risk patients for OHSS
Public title
Evaluation of oral calcium effect in prevention OHSS (ovarian hyperstimulation syndrome) in high-risk patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- Antagonist protocol for Assisted reproductive technology (ART)
2- ) 2- The number of follicles ≥ 20 mm is over 20.
3- The plasma estradiol level ≥ 2500pg/ml
Exclusion criteria:
1-patients with the endocrine disease as Diabetes mellitus, hyperprolactinemia, Cushing disease, congenital adrenal hyperplasia
2- Patients with the systemic disease as asthma, collagen vascular disease, hypercholesterolemia, cycle cell anemia
3- History of neoplasm
4-The plasma estradiol level is high (over 6000pg/ml).
5- Use of insulin-sensitization drugs
6- Patients that were required to the need to cycle cancellation.
Age
From 16 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization with random statistics
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, simple randomization method is used and the patients had no information about the types of drug (calcium or placebo), but the nurses and doctors had full information about the types of drug.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ̓s Tehran university of medical sciences
physical exam, transvaginal sonography and blood exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with moderate to severe Ovarian Hyperstimulation Syndrome (OHSS) that received Calcium Carbonate 500mg orally every 12 hours for 5 days after injection of HCG or recombinant HCG
Category
Prevention
2
Description
Control group( Placebo group): Patients with moderate to severe OHSS that received oral placebo orally every 12 hours for 5 days after injection of HCG or recombinant HCG