NCT00349258

Brief Summary

To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
Last Updated

July 6, 2006

Status Verified

February 1, 2006

First QC Date

July 5, 2006

Last Update Submit

July 5, 2006

Conditions

Ovarian Hyperstimulation Syndrome

Keywords

OHSSPCOSPrevious high responseGnRH antagonistGnRH agonistIVF

Outcome Measures

Primary Outcomes (2)

  • OHSS occurrence assessed one week after oocyte retrieval

  • Implantation rate assessed at seven weeks gestation

Secondary Outcomes (3)

  • Clinical Pregnancy rate assessed at time of ultrasound

  • Mature oocytes assessed at time of retrieval

  • Ovarian volume assessed one week after oocyte retrieval

Interventions

Leuprolide acetateDRUG

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20-39
  • normal early follicular phase serum FSH (≤10.0 IU/l)
  • patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.

You may not qualify if:

  • Hypogonadotropic hypogonadism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Advanced Reproductive Services, UCHC

Farmington, Connecticut, 06032, United States

Location

Related Publications (1)

  • Engmann L, Romak J, Nulsen J, Benadiva C, Peluso J. In vitro viability and secretory capacity of human luteinized granulosa cells after gonadotropin-releasing hormone agonist trigger of oocyte maturation. Fertil Steril. 2011 Jul;96(1):198-202. doi: 10.1016/j.fertnstert.2011.04.071. Epub 2011 May 20.

    PMID: 21601197DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Claudio Benadiva, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

  • Lawrence Engmann, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

August 1, 2004

Study Completion

May 1, 2006

Last Updated

July 6, 2006

Record last verified: 2006-02

Locations

US(1)