Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

Overview

Giving oral Cabergoline or calcium infusion in women at high risk for developing ovarian hyperstimulation syndrome in context of assisted reproductive technologies aiming in its prevention

Full Title of Study: “Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 15, 2017

Detailed Description

Women undergoing in vitro fertilization or intracytoplasmic sperm injection whom were at high risk for developing ovarian hyperstimuation syndrome were received either oral Cabergoline.5mg tablets for 7days starting on ovum pick up day and continued for 7days or received 10ml of 10lcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Interventions

  • Drug: Oral Cabergoline
    • Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days
  • Drug: Calcium Gluconate
    • Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days

Arms, Groups and Cohorts

  • Active Comparator: Calcium infusion
    • 10ml 10lcium gluconate in 200ml normal saline solution given intravenously over thirty minutes, on ovum pick up day and continued for 4days
  • Active Comparator: Oral Cabergoline
    • Receiving oral Cabergoline (cabergamon 0.5 milligram tablet ) from ovum pick up day and continued for 7days,once daily

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of ovarian hyperstimuation syndrome
    • Time Frame: 20 days from ovum pick up day
    • Clinical condition occurred in context of assisted reproductive technologies in which there serous sacs fluid accumulation and hemoconcentration

Secondary Measures

  • Types of ovarian hyperstimuation syndrome and severity
    • Time Frame: 20 days from ovum pick up day
    • Clinical severity either mild ,moderate or severe and its type either early or late onst
  • Chemical pregnancy
    • Time Frame: 14 day from embryos transfer day
    • Positive human chorionic Gonadotropin in blood
  • Clinical pregnancy
    • Time Frame: 5 week from embryos transfer day
    • Intrauterine gestational sac

Participating in This Clinical Trial

Inclusion Criteria

  • women undergoing assisted reproductive technologies whom at high risk for developing ovarian hyperstimulation syndrome as with high basal antimullerian hormone ,excess antral follicular count ,high seum estradiol on day of humian choronic gonadotrophin Exclusion Criteria:

women with other endocrinopathy as congenital adrenal hyperplasia , hyperprolactinemia,diabetes -

Gender Eligibility: Female

Women undergoing assisted reproductive technologies

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Benha University
  • Provider of Information About this Clinical Study
    • Principal Investigator: ashraf nassif mahmoud elmantwe,MD, Assistant professor – Benha University
  • Overall Official(s)
    • Ashraf N Elmantwe, MD, Principal Investigator, Benha University

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