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OpenTrials
Completed

NCT Number: NCT02271360

Calcium Dobesilate Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

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).

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

22 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Benha univesity hospital

Banhā, El Qualyobia, 13518, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium Dobesilate

Drug

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

Other names: doxium

cabergoline

Drug

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

Other names: Dostinex

Primary outcomes

  1. Number of participants with ovarian hyperstimulation syndrome (OHSS)

    Time frame: 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 outcomes

  1. pregnancy rate

    Time frame: 14 days after embryos transfer

    β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Feb 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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