Follicular Flushing Outcomes in Singles Versus Double Lum... | NCT02391155

Studies
Follicular Flushing Outcomes in Singles Versus Double Lumen Oocyte Retrieval Needles in Poor Responding Patients

NCT02391155

Sponsor

Baskent University

Status

Completed

Last Update Posted

Jul 2, 2018Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

single lumen needle in oocyte retrieval
double lumen needle in oocyte retrieval

Countries

Turkey (Türkiye)

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

Mar 2015

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

Jan 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Feb 11, 2015

First Submission Date that Met QC Criteria

Mar 11, 2015

First Posted Date

Mar 18, 2015Estimated

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 29, 2018

Last Update Posted Date

Jul 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bulent Haydardedeoglu, Assoc. Prof. M.D. Bulent Haydardedeoglu, Baskent UniversityPrincipal Investigator

Lead Sponsor

Baskent UniversityOTHER

Collaborators

Not provided

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

In this study, the investigators aimed to evaluate to the efficacy of the needle type used in follicular flushing in oocyte retrieval in the poorest responders undergoing IVF.

Detailed Description

This study will include:

women with less than four follicles on the day of hCG administration
women between 20-45 age old
The value of progesterone on the day of hCG administration will be under 1.5ng/ml

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single lumen	Active Comparator	Single lumen needle in oocyte retrieval	Procedure: single lumen needle in oocyte retrieval Procedure: double lumen needle in oocyte retrieval
double lumen	Active Comparator	Double lumen needle with follicle flushing during oocyte retrieval	Procedure: single lumen needle in oocyte retrieval Procedure: double lumen needle in oocyte retrieval

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single lumen needle in oocyte retrieval	Procedure	single lumen needle use during oocyte retrieval	double lumen single lumen

Measure	Description	Time Frame
number of metaphase 2 oocyte		Six months

Measure	Description	Time Frame
clinical pregnancy rate		eigth months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women between 20-45 years old
the number of follicles less than 5 on the day of HCG administration
the value of progesteron on the day of hCG administration must be under 1.5ng/ml

Exclusion Criteria:

women under 20 years and older than 45 year
on the day of hCG administration if the follicle number is more than 5
if.the value of progesteron on the day of hCG administration is higher than 1.5ng/ml

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bulent Haydardedeoglu		Adana		01120	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D054315	Oocyte Retrieval

Ancestor Terms

ID	Term
D027724	Reproductive Techniques, Assisted
D012099	Reproductive Techniques
D013812	Therapeutics
D020858	Tissue and Organ Harvesting

Browse Leaves

Not provided

Browse Branches

Not provided