Diosmin plus cabergoline for prevention of Ovarian Hyperstimulation Syndrome in high-risk women undergoing intracytoplasmic sperm injection (ICSI)

Phase 3

Recruiting

• Conditions: infertile women; Ovarian Hyperstimulation Syndrome; PCO (polycystic ovarian syndrome); Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12614000535673
• Lead Sponsor: khalid abd aziz mohamed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

infertile women with or without polcystic ovarian syndrome and candidate forICSI with one of the following:

1.Presence of more than 20 follicles by ultrasound
2.E2 more than 3000 pg/ml
3.Retrieval of more than 15 follicles

Exclusion Criteria

none

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of ovarian hyperstimulation syndrome(OHSS)<br>will be assessed :<br>A.Clinically: <br>1.Abdominal bloating<br>2.Mild abdominal pain<br>3.Nausea +/- vomiting<br>4.Oliguria<br>5.Acute respiratory distress syndrome<br>B.By ultrasound<br>1.Ovarian size usually greater than 8 cm<br>2.Ultrasound evidence of ascites<br>C.Laboratory<br>1.haematocrit greater than 45%<br>2.Hypoproteinaemia<br>[will be assessed every two weeks after retrieval and for 8 weeks]

Secondary Outcome Measures

Name	Time	Method
the pregnancy rate <br><br> will be assessed by :serum hCG test[Beta sub-unit of hCG (serum hCG test)<br>was checked 16 days after embryos transfer]