The Influence of Timing of Cabergoline Initiation on Prevention of OHSS (OHSS)
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Late Cabergoline 0.5mg
Early Cabergoline 0.5mg
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring Cabergoline, Ovarian Hyper Stimulation Syndrome (OHSS)
Eligibility Criteria
Inclusion Criteria:
- Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
- 18 or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger
Exclusion Criteria:
- patient with one ovary
- patients already receiving cabergoline treatment
- Severe Male factor infertility.
- Thyroid dysfunction.
Sites / Locations
- IVF department in Kasr Alaini hospital,private IVF centreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Late administration of Cabirgoline 0.5 mg
Early administration of Cabirgoline 0.5mg
Arm Description
Cabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days.
Cabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger.
Outcomes
Primary Outcome Measures
Occurrence and severity of OHSS
either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit >45%; white blood cell count >15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)
Secondary Outcome Measures
Number of M|| oocytes.
Fertilization rate.
fertilization rate (the presence of two pronuclei (2PN) at the time of fertilization assessment, 16 to 19 hours after ICSI),
Clinical Pregnancy rate
Clinical pregnancy was considered to be the presence of a gestational sac with fetal heart activity.
implantation rate
implantation rate( the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02620605
Brief Title
The Influence of Timing of Cabergoline Initiation on Prevention of OHSS
Acronym
OHSS
Official Title
The Influence of Timing of Cabergoline Initiation on Prevention of Ovarian Hyper Stimulation Syndrome in Patients Undergoing Intra Cytoplasmic Sperm Injection .
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mona M Shaban
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate..
Detailed Description
Patients less than 35years undergoing Intra Cytoplasmic Sperm Injection for infertility scheduled for gonadotropin releasing hormone agonist long protocol of ovarian stimulation.
All patient will receive combined oral contraceptive pills (Gynera, Schering-plow: plough) starting from day 5 of cycle that precedes the stimulated cycle .On day 21 of that cycle all patients will start to receive Gonadotrophin releasing hormone agonist in the form of (decapeptyl 0.1 sc daily and continued till the day of HCG administration).
To ensure that all patients are completely down regulated and desensitized ,trans-vaginal ultrasound will be performed at day 2-3 of menses of stimulated cycle to ensure endometrial thickness less than 5 mm and no ovarian cysts.Also serum E2 level is less than 50 pg/ml.
Then all patients will start to receive Gonadotrophin ( HMG) (Menogon, ferring pharmaceuticals, Germany) 225 IU (international unit) Intramuscular Injection daily,with continuous scheduled follow up of ovarian response by serial trans -vaginal US to assess follicular growth together will serial serum E2 starting from day 6 of cycle and onwards.With adjustments of gonadotropin dose and monitoring frequency based on patient response.
During follow up once the recruited patients fulfilling the inclusion criteria (serum E2 equal or more than 4000 pg/ml and /or 18 or more follicles of 11 mm diameter or more at any day of stimulation),they will be allocated randomly by computer generated cards and assigned by sealed envelopes by the treating doctor at the outpatient clinic.
Group A : will receive cabergoline 0.5 mg/day for 8 days, starting in the day of HCG (human chorionic gonadotropin ) injection.
Group B: will receive cabergoline 0.5 mg/day once the criteria of inclusion criteria is fulfilled and continued till the day of human chorionic gonadotropin (HCG ) trigger and continued 8 days more from day of trigger .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
Cabergoline, Ovarian Hyper Stimulation Syndrome (OHSS)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Late administration of Cabirgoline 0.5 mg
Arm Type
Active Comparator
Arm Description
Cabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days.
Arm Title
Early administration of Cabirgoline 0.5mg
Arm Type
Experimental
Arm Description
Cabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger.
Intervention Type
Drug
Intervention Name(s)
Late Cabergoline 0.5mg
Other Intervention Name(s)
Dostenix (Dostinex®, Pfizer Australia Pty Ltd )
Intervention Description
Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days
Intervention Type
Drug
Intervention Name(s)
Early Cabergoline 0.5mg
Other Intervention Name(s)
Dostinex (Dostinex®, Pfizer Australia Pty Ltd )
Intervention Description
Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.
Primary Outcome Measure Information:
Title
Occurrence and severity of OHSS
Description
either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit >45%; white blood cell count >15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)
Time Frame
2 to 4weeks after trigger
Secondary Outcome Measure Information:
Title
Number of M|| oocytes.
Time Frame
maximum one day after ovum pick up
Title
Fertilization rate.
Description
fertilization rate (the presence of two pronuclei (2PN) at the time of fertilization assessment, 16 to 19 hours after ICSI),
Time Frame
16 to 19 hours after ICSI
Title
Clinical Pregnancy rate
Description
Clinical pregnancy was considered to be the presence of a gestational sac with fetal heart activity.
Time Frame
2 to 4 weeks after positive pregnancy test
Title
implantation rate
Description
implantation rate( the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred)
Time Frame
2 to 4 weeks after positive pregnancy test
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
18 or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger
Exclusion Criteria:
patient with one ovary
patients already receiving cabergoline treatment
Severe Male factor infertility.
Thyroid dysfunction.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherine H Gad Allah, MD
Phone
01097665573
Ext
+2
Email
sherinehosny@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
mona M Shaban, MD
Phone
01001078586
Ext
+2
Email
monashaban75@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona M Shaban, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVF department in Kasr Alaini hospital,private IVF centre
City
Cairo
ZIP/Postal Code
1325
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherine H Gad Allah, MD
Phone
01097665573
Ext
+2
Email
sherinehosny@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Influence of Timing of Cabergoline Initiation on Prevention of OHSS
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