Back to results

Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

Primary Purpose

Infertility

Status

Completed

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Calcium Dobesilate

coasting

About this trial

This is an interventional prevention trial for Infertility

Eligibility Criteria

23 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Benha univesity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

group A

group B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of participants with ovarian hyperstimulation syndrome (OHSS)

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

pregnancy rate

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

Full Information

NCT ID

NCT02290002

First Posted

November 8, 2014

Last Updated

February 13, 2017

Sponsor

khalid abd aziz mohamed

1. Study Identification

Unique Protocol Identification Number

NCT02290002

Brief Title

Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

Official Title

Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

khalid abd aziz mohamed

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

group A

Arm Type

Active Comparator

Arm Description

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.

Arm Title

group B

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Calcium Dobesilate

Other Intervention Name(s)

doxium

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

coasting

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with ovarian hyperstimulation syndrome (OHSS)

Description

Time Frame

every two weeks for eight weeks

Secondary Outcome Measure Information:

Title

pregnancy rate

Description

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

Time Frame

14 days after embryos transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

23 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ahmed saad, MD

Organizational Affiliation

lecturer of ob/gyn

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

khalid mohamed, MD

Organizational Affiliation

lecturer of ob/gyn

Official's Role

Study Director

Facility Information:

Facility Name

Benha univesity hospital

City

Benha

ZIP/Postal Code

13518

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

We'll reach out to this number within 24 hrs