Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

Trial website

Contact information



Primary contact

Prof Amany Shaltout


Contact details

Dr Samir Abbas Medical Center
PO Box 12190
Saudi Arabia
+966 50 767 5438

Additional identifiers

EudraCT number number

Protocol/serial number

SAC 05-12011

Study information

Scientific title

Cabergoline and OHSS - a randomized controlled study



Study hypothesis

Capillary permeability is the end step of the cascade of the pathophysiology of OHSS which is associated with third space fluid accumulation and fluid shift. Vascular endothelial growth factor (VEGF) is one of the vasoactive mediators which increases capillary permeability and expressed at a higher level in the granulose cells. The administration of a dopamine agonist in immature rats at low doses simultaneously with human chorionic gonadotropin (HCG) prevented an increase in vascular permeability and did not affect angiogenesis; the effect was due to the availability of dopamine type 2 receptors. Dopamine agonists prevent the phosphorylation of VEGF receptor 2 and reduce the in vitro and in vivo release of vasoactive angiogenic agents. As a result, vascular permeability is also reduce. Consequently, dopamine agonist has been supposed to be a potential new strategy to prevent OHSS and reduce the severity.

Ethics approval

Samir Abbas Ethical Board, December 2006

Study design

Single center, non blinded, randomized controlled study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Ovarian hyperstimulation syndrome (OHSS)


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.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Incidence, onset and severity of OHSS

Secondary outcome measures

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 β-HCG test)

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients with dopamine E2 ≥5000 pg/ml

Recruitment start date


Recruitment end date



Countries of recruitment

Saudi Arabia

Trial participating centre

Dr Samir Abbas Medical Center
Saudi Arabia

Sponsor information


Samir Abbas Center (Saudi Arabia)

Sponsor details

Samir Abbas Medical Center
PO Box 12190
Saudi Arabia
+966 50 767 5438

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in:

Publication citations

  1. Results

    Youssef MA, van Wely M, Hassan MA, Al-Inany HG, Mochtar M, Khattab S, van der Veen F, Can dopamine agonists reduce the incidence and severity of OHSS in IVF/ICSI treatment cycles? A systematic review and meta-analysis., Hum. Reprod. Update, 16, 5, 459-466, doi: 10.1093/humupd/dmq006.

Additional files

Editorial Notes