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Completed

NCT Number: NCT02134249

Diosmin Versus Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome

The purpose of this study is to compare the effect of oral Diosmin 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

23 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Banha Universty, Banhā, El Qalubia, Egypt

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About this study

Two hundred women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Diosmin group), 2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for 2 weeks ; while in group B (Cabergoline group), 1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for eight days.

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 ovarin 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

Diosmin

Drug

2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days

Other names: Daflon

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: every week for eight weeks

    Diagnosis of OHSS was made according to the criteria of Golan et al.. Mild OHSS was classified as: Grade 1 (abdominal distension and discomfort) and Grade 2 (features of grade 1 plus nausea, vomiting and/or diarrhea; ovaries are enlarged from 5 to 12 cm), moderate OHSS as Grade 3 (features of mild OHSS plus ultrasonic evidence of ascites), severe OHSS as Grade 4 (features of moderate OHSS plus evidence of ascites and/or hydrothorax and breathing difficulties) and Grade 5 (all of the above, plus change in the blood volume, increased blood viscosity due to hemoconcentration, coagulation abnormality, and diminished renal perfusion and function).

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

Acronym: infertility

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 9, 2014
Registry last updated
Feb 2, 2016

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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