Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02271360

Enrollment

200

Registered

2014-10-22

Start date

2014-04-30

Completion date

2015-12-31

Last updated

2017-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

infertility ICSI OHSS Calcium Dobesilate Cabergoline

Brief summary

The purpose of this study is to compare the effect of oral Calcium Dobesilate to oral Cabergoline in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Detailed description

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 21 days; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days.

Interventions

DRUGCalcium Dobesilate

1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days

DRUGCabergoline

1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

22 Years to 44 Years

Healthy volunteers

Inclusion criteria

Patients enrolled in the study were infertile women undergoing ICSI with one of the following criteria: previous episodes of OHSS, polycystic ovaries (i.e., \> 24 antral follicles present on baseline ultrasound examination), high AMH (\> 3.0 ng/mL), large number of small follicles (8 to 12 mm) seen on ultrasound during ovarian stimulation, high s.E2 at hCG trigger (E2 \>3000 pg/ml or rapidly rising s.E2), presence of \> 20 follicles by ultrasound on day of retrieval or large number of oocytes retrieved (\> 20).

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with ovarian hyperstimulation syndrome (OHSS)	weekly for eight weeks	this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia

Secondary

Measure	Time frame	Description
pregnancy rate	14 days after embryos transfer	β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026