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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 July 2017 |
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Main ID: |
ISRCTN42536405 |
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Date of registration:
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19/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Can a dopamine agonist prevent severe ovarian hyperstimulation syndrome (OHSS) in women undergoing intracytoplasmic sperm injection (ICSI) treatment cycles?
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Scientific title:
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Cabergoline and OHSS - a randomized controlled study |
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Date of first enrolment:
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01/07/2007 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN42536405 |
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Study type:
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Interventional |
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Study design:
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Single-center non-blinded randomized controlled study (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Amany
Shaltout |
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Address:
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Dr Samir Abbas Medical Center
PO Box 12190
21473
Jeddah
Saudi Arabia |
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Telephone:
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+966 (0)50 767 5438 |
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Email:
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amanyshaltout@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. 200 infertile couples undergoing ICSI and at risk of developing OHSS have been included between January 2007 and July 2009
2. The risk to develop OHSS has been defined as follows:
2.1. Dopamine E2 level on day of hCG > 3500 pg/ml
2.2. With = 20 follicles > 12 mm
Exclusion criteria: Patients with dopamine E2 =5000 pg/ml
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian hyperstimulation syndrome (OHSS)
Pregnancy and Childbirth
Ovarian hyperstimulation syndrome (OHSS)
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Intervention(s)
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1. Long mid luteal GnRH agonist protocol, 0.1 mg triptorelin SC. (Decapeptyl; Ferring; Germany) has been used for pituitary down regulation in both groups
2. Once pituitary down regulation has been confirmed, controlled ovarian hyperstimulation (COH) was started using fixed dose of HMG, 150- 225 IU (Menogon 75 IU,IM injections, Ferring, Germany), for 5 days, then the dose was adjusted according to response
3. When 3 leading follicles reached 18 mm, final oocyte maturation was triggered with a single dose of 5000 IU of hCG
4. On day of hCG administration, couples were randomized using computer generated list with closed opaque envelops into two groups, cabergoline group (Group I; n=100), received 0.25 mg daily for 8 days and non-cabergolone group (Group II; n=100), did not receive cabergoline
5. Transvaginal guided oocyte retrieval was performed 34 - 36 hours later
6. Both groups have been administrated 500 ml of hydroxyethyl starch (HES) over 30 minutes as a routine strategy in our center on the day of ovum pickup
7. Ultrasound guided transfer (ET) of 2-3 embryos was performed 72 hours later
8. Luteal phase was supported with 400 mg progesterone vaginal pessaries, twice daily up to the day of pregnancy test (Cyclogest; Cox Pharmaceuticals, Whiddon Valley, UK)
9. Haemoconcentration, presence of ascitis, measuring the perpendicular diameter of free fluid in Douglas Pouch, and the ovarian volume have been reported in both groups on day of ET
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Primary Outcome(s)
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Incidence, onset and severity of OHSS
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Secondary Outcome(s)
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1. Oocyte recovery rate
2. Number of mature oocytes
3. Fertilization rate
4. Clinical pregnancy rate (defined as presence of fetal heart pulsation 2 weeks after a positive ß-HCG test)
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Secondary ID(s)
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SAC 05-12011
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Source(s) of Monetary Support
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Investigator initiated and funded
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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