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Completed

NCT Number: NCT01427335

Calcium for Prevention of Ovarian Hyperstimulation Syndrome

There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS & the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect & the real mechanism for its action.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

20 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kasr elini hospital

Cairo, Cario, 12211, Egypt

About this study

The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.

Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.

Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • infertile women aged 20 to 38 years.
  • BMI ranged from 18 to 40.
  • serum FSH within normal limits( 1-12IU /l)
  • presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion criteria

  • endocrinopathies.
  • a systemic disease.
  • using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
  • patients need coasting for high risk of OHSS.
  • patients need cycle cancellation.
  • severe male infertility requiring testicular sperm extraction.

Treatment and study plan

calcium

Drug

intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group.

Intravenous infusion was performed within 30 minutes

Other names: Calcium intravenous infsuion

0.9 % saline

Drug

0.9 % saline intravenous infusion

Primary outcomes

  1. OHSS rate

    Time frame: 2 years

    ovarain hyperstimulation syndrome

Secondary outcomes

  1. clinical pregnancy rate

    Time frame: 2 years

    positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial

Acronym: OHSS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2011
Registry last updated
Jul 9, 2014

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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