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Completed

NCT Number: NCT02290002

Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing 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

23 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Benha univesity hospital

Banhā, 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 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:
  • Presence of more than 20 follicles by ultrasound
  • E2 more than 3000 pg/ml
  • Retrieval of more than 15 follicles

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

coasting

Other

In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done

Primary outcomes

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

    Time frame: every two weeks 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

khalid abd aziz mohamed

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 13, 2014
Registry last updated
Feb 14, 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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