Temporally Splitting Ovarian Stimulation and Embryo Transfer | NCT00795041

Studies
Temporally Splitting Ovarian Stimulation and Embryo Transfer

NCT00795041

Sponsor

University of Luebeck

Status

Completed

Last Update Posted

Oct 18, 2010Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Splitting of Ovarianstimulation and Embryotransfer

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

Status Module

Record Verification Date

Nov 2008

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

Nov 2008

Primary Completion Date

Jun 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Nov 20, 2008

First Submission Date that Met QC Criteria

Nov 20, 2008

First Posted Date

Nov 21, 2008Estimated

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

Oct 15, 2010

Last Update Posted Date

Oct 18, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to explore the concept of temporally splitting ovarian stimulation and embryo transfer.

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

10Actual

Label	Type	Description	Intervention Names
1		10 women with indication for ART with ICSI or IVF

Measure	Description	Time Frame
Ongoing pregnancy rate		November 2008- May 2009

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for IVF/ICSI
Age 18-36 years
<= three earlier unsuccessful IVF/ICSI treatments with embryo transfer
BMI 20-30
Regular cycle with ovulation (28-35 days)
Progesterone >7ng/ml at the beginning of stimulation
Informed consents

Exclusion Criteria:

PCOS (polycystic ovarian syndrome
Endometrioses >= grade 3
Known poor response syndrome
History of ovariectomy
Severe endocrinopathie

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

women with indication for ART with ICSI or IVF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Georg Griesinger, PD MD	University of Schleswig-Holstein, Campus Luebeck, Department of Obstetrics and Gynecology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Schleswig Holstein, Campus Luebeck, Department of Obstetrics and Gynecology		Lübeck	Schleswig-Holstein	23538	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23545834	Derived	Buendgen NK, Schultze-Mosgau A, Cordes T, Diedrich K, Griesinger G. Initiation of ovarian stimulation independent of the menstrual cycle: a case-control study. Arch Gynecol Obstet. 2013 Oct;288(4):901-4. doi: 10.1007/s00404-013-2794-z. Epub 2013 Apr 3.