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Completed

NCT Number: NCT03473613

Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention

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

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Key information

Conditions

Ovarian Hyperstimulation

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ashraf nassif Elmantwe

Cairo, Elqalopia, 5131, Egypt

About this study

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 10%calcium gluconate in 200ml normal saline on ovum pick up day and continued for 4days

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Oral Cabergoline

Drug

Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days

Other names: Cabergamon

Calcium Gluconate

Drug

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

Other names: Calcium

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Chemical pregnancy

    Time frame: 14 day from embryos transfer day

    Positive human chorionic Gonadotropin in blood

  3. Clinical pregnancy

    Time frame: 5 week from embryos transfer day

    Intrauterine gestational sac

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Comparison of Cabergoline Versus Calcium Infusion in Ovarian Hyperstimulation Syndrome Prevention:Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 22, 2018
Registry last updated
Mar 29, 2018

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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