Combining Cabergoline and Coasting in Gonadotropin Releasing Hormone(GnRH)Agonist Protocol in Intracytoplasmic Sperm Injection (ICSI) to Prevent Ovarian Hyperstimulation Syndrome (OHSS): a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cairo University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Rate and degree of OHSS (composite outcome)
Study Overview
Brief Summary
The effectiveness of cabergoline to prevent moderate-severe OHSS to coasting.
Detailed Description
To randomly compare three study groups under a high risk of developing OHSS to one of three arms of management, either coasting for 1 to 3 days or receiving cabergoline for 8 days or coasting for 1 day plus receiving cabergoline for 8 days in ICSI patients following the long luteal GnRH agonist protocol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age <or= 35, BMI <or= 30
- •Long protocol GnRH agonist cycles
- •Estradiol level on day of HCG >or= 3500 pg/ml
- •Retrieving more than 15 oocytes
Exclusion Criteria
- •Male factor
- •Uterine factor
Arms & Interventions
Coasting
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.
Intervention: ICSI (Procedure)
Cabergoline
In their ICSI cycle patients will take 0.25 mg of cabergoline daily for 8 days from HCG triggering day 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.
Intervention: ICSI (Procedure)
Coasting and Cabergoline
In their ICSI cycle patients will continue their agonist treatment while stopping the human menopausal gonadotropin (hMG) injections for 1 day plus receiving 0.25 mg of cabergoline daily for 8 days from HCG triggering day 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.
Intervention: ICSI (Procedure)
Outcomes
Primary Outcomes
Rate and degree of OHSS (composite outcome)
Time Frame: 14 days
Symptoms of nausea, vomiting, shortness of breath, abdominal pain,abdominal distension. Ovarian size and fluid in douglas pouch by ultrasound. Haematocrit, total leucocytic count, creatinine and Estradiol level as biochemical markers. Early OHSS first 9 days after ovum pickup and late is after 9 days till 14 days (time of pregnancy test)
Secondary Outcomes
- Number of oocytes(1 day)
Investigators
Yasmin Ahmed Bassiouny
MD
Cairo University