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Trial · Interventional

CompletedNot applicableResults postedRegistry data

The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors

NCTNCT00867659 (opens ClinicalTrials.gov in a new tab)Other idVCRM2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
20 participants (actual)
Sponsor
Virginia Center for Reproductive Medicine · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

United States

Start
Mar 2009
Primary completion
Oct 2011
Completion
Oct 2011
First posted
24 Mar 2009 (estimated)
Last update posted
27 Mar 2013 (estimated)
Conditions
Ovarian Hyperstimulation Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2009201020112012
  1. N/A

    The Role of Cetrotide Acetate in Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in Oocyte Donors

    NCT00867659

    Mar 2009 to Oct 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This pilot study aims to address whether the prophylactic use of Cetrorelix Acetate after a long gonadotropin-releasing hormone (GnRH) agonist protocol post-hCG (human chorionic gonadotropin) administration can significantly reduce the incidence of OHSS in oocyte donors.

Interventions

  • Cetrotide acetateDrug

Arms1

  • Experimental

    Cetrotide acetate

    oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS

    Time frame · 4 weeks

    Registry description

    evaluate by ultrasound examination, physical examination and blood work the incidence of ovarian hyperstimulation syndrome in oocyte donors receiving a single injection of 3 mg Cetrotide Acetate.

  2. Ovarian Volumes as a Predictor of OHSS Severity

    Time frame · 30 days

    Registry description

    ultrasound measurements of both ovaries

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 4 weeks

Volume of Ascites in the Abdomen is Indicative of the Severity of OHSS

GroupValue (cc (volume of ascites))
Cetrotide Acetate10
Primary outcomeMean· 30 days

Ovarian Volumes as a Predictor of OHSS Severity

GroupValue (cc)
Cetrotide Acetate25

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Cetrotide Acetateoocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.–0 / 200 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 19 Years up to 32 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Prospective donors with BMIs between 19 and 28, * Those with normal FSH levels and good antral follicle counts between 19-28 years of age, AND * Donors would have passed all the required testing as mandated by VCRM and the FDA. Exclusion Criteria: * Oocyte donors exceeding a BMI of \> 28, * Those with any communicable diseases, * Those with low antral follicle counts and small ovarian volumes, * Those with elevated FSH levels, * Those with positive sickle cell screen or cystic fibrosis screening, * Smokers, OR * Donors who are unable or unwilling to follow the research protocols.

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