Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

Phase 2

Completed

• Conditions: Infertility
• Interventions: Other: coasting; Drug: Calcium Dobesilate

• Registration Number: NCT02290002
• Lead Sponsor: khalid abd aziz mohamed

Brief Summary

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).

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 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

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-11-08
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	coasting	In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
group A	Calcium Dobesilate	In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days.

Primary Outcome Measures

Name	Time	Method
Number of participants with ovarian hyperstimulation syndrome (OHSS)	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 Outcome Measures

Name	Time	Method
pregnancy rate	14 days after embryos transfer	β-hCG (serum hCG test) will be checked 14 days after embryos transfer

Trial Locations

Locations (1)

Benha univesity hospital; 🇪🇬 Benha, Egypt