Ovarian Hyperstimulation Syndrome (OHSS) Prevention With... | NCT00835523

Studies
Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

NCT00835523

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Jun 14, 2012Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

OHSS Prevention by GnRH-agonist Triggering of Final Oocyte Maturation and Cryoperservation of All Two-pronucleate Oocytes in Women Undergoing Stimulation for IVF With Gonadotrophins and GnRH-analogues: a Prospective, Observational, Multicentric, Clinical Cohort Study

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Feb 2, 2009

First Submission Date that Met QC Criteria

Feb 2, 2009

First Posted Date

Feb 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georg Griesinger, Director of Department of Reproductive Medicine, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Label	Type	Description	Intervention Names
OHSS risk

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months		12 months after recruitment

Secondary Outcomes

Measure	Description	Time Frame
ongoing pregnancy rate/frozen-thawed ET		12 months after recruitment
Ongoing pregnancy rate/first frozen-thawed ET		12 months after recruitment
time to pregnancy in weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for IVF with ICSI
Age < 40 years
< 4 failed previous IVF attempts with embryo transfer
ovarian stimulation with GnRH-antagonist and gonadotrophins
>20 follicles >11 mm in mean diameter or E2 >4500 pg/ml on the day , on which it was planned to administer hCG
willing to participate and able to consent
patient has not previously received GnRH-agonist as a trigger of final oocyte maturation

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

39 Years

Standard Ages

Adult

Study Population

IVF patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Griesinger, PD Dr. med.	Department of Obestrics and Gynecology, University Clinic of Schleswig-Holstein, Campus Luebeck	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVF-Augsburg		Augsburg		86150	Germany
Deutsche Klinik Bad Münder

Condition Browse Module

MeSH Terms

ID	Term
D016471	Ovarian Hyperstimulation Syndrome

Ancestor Terms

ID	Term
D010049	Ovarian Diseases
D000291	Adnexal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided