Gynecologic Disease
Conditions
Brief summary
Ovarian hyperstimulation syndrome (OHSS) is a serious iatrogenic complication of controlled ovarian stimulation of gonadotrophin-Stimulated ovarian cycles. It is theorized to manifest systemically as a result of vasoactive mediators like vascular endothelium growth factor (VEGF) being released from hyperstimulated ovaries. As a result, capillary permeability is increased which causes the extravasation of fluid from the intravascular compartment into the third space. The haemoconcentration which ensues results in complications such as hypercoagulability and reduced end organ perfusion.
Interventions
PROCEDURECoasting
In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 to 3 days until drop of estradiol to a safe level to prevent OHSS. Early OHSS is assessed at day of embryo transfer and 7 days after this date. Late OHSS is assessed 14 days after embryo transfer.
DRUGCabergoline
Cabergoline is used to treat different types of medical problems that occur when too much of the hormone prolactin is produced. It can be used to treat certain menstrual problems, fertility problems in men and women, and pituitary prolactinomas
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18-38 years * Body mass index (calculated as weight in kilograms divided by the square of height in meters) \< 30 kg/m2. * A long luteal protocol is used for ovarian stimulation. * Day 2 FSH \<10 mIU/L and E2\< 50 pg/ml * High risk of OHSS, defined as having more than 20 follicles \>12 mm in diameter and/or E2 levels \> 3000 pg/ml when the size of the leading follicle is \> 15 mm
Exclusion criteria
The presence of chronic medical diseases, including liver cell failure, renal failure, uncontrolled hypertension, uncontrolled diabetes mellitus, or class 3 or 4 function heart disease in the New York heart association classification. Allergy to Cabergoline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence and severity of OHSS | 1 month | The primary outcome of this study is the occurrence and severity of OHSS. OHSS was defined as abdominal pain and distention associated with nausea and vomiting and ovarian enlargement \> 8 cm. The severity of OHSS will be assessed (mild, moderate, severe, and clinical) according to the American Society for Reproductive Medicine guidelines |
Countries
Egypt
Outcome results
None listed