OHSS
Conditions
Keywords
OHSS, ICSI, Coasting, Cabergoline
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.
Interventions
PROCEDUREICSI
Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Age \<or= 35, BMI \<or= 30 2. Long protocol GnRH agonist cycles 3. Estradiol level on day of HCG \>or= 3500 pg/ml 4. Retrieving more than 15 oocytes
Exclusion criteria
1. Male factor 2. Uterine factor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and degree of OHSS (composite outcome) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes | 1 day | Number of oocytes collected on the day of oocyte collection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of embryos | 3 to 5 days | Number of embryos assessed for embryo transfer in each patient |
| Implantation rate | 5 weeks | the ratio of the number of gestational sacs to the number of embryos transferred |
| Chemical pregnancy rate | 14 days | The patients who have a positive quantitative Beta human chorionic gonadotrophin (BHCG) and do not continue their pregnancy with a drop in the result and start of menstruation |
| Number of Metaphase II (MII) oocytes | 1 day | Number of MII oocytes collected on the day of oocyte collection |
| Early miscarriage rate | 12 weeks | pregnancy loss in the first 12 weeks of gestation |
| Ongoing pregnancy rate | 12 weeks | pregnancies going beyond 12 weeks of gestation |
| Live birth rate | 40 weeks | live births occuring |
| Clinical pregnancy rate | 28 days | patients who show an intra-uterine gestational sac with positive fetal pulsations on ultrasound 14 days after their pregnancy test |
| Fertilization rate | 2 days | Number of embryos that show signs of fertilization in each patient |
Countries
Egypt
Outcome results
None listed