NCT02391155

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 2, 2018

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

February 11, 2015

Last Update Submit

June 29, 2018

Conditions

Infertility

Keywords

follicular flushingIVFpoor respondersoocyte retrival

Outcome Measures

Primary Outcomes (1)

  • number of metaphase 2 oocyte

    Six months

Secondary Outcomes (1)

  • clinical pregnancy rate

    eigth months

Study Arms (2)

single lumen

ACTIVE COMPARATOR

Single lumen needle in oocyte retrieval

Procedure: single lumen needle in oocyte retrievalProcedure: 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 retrievalProcedure: double lumen needle in oocyte retrieval

Interventions

single lumen needle in oocyte retrievalPROCEDURE

single lumen needle use during oocyte retrieval

double lumensingle lumen
double lumen needle in oocyte retrievalPROCEDURE

after aspiration of follicles, 3 times flushing will be performed in double lumen needle.

double lumensingle lumen

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulent Haydardedeoglu

Adana, 01120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsTissue and Organ HarvestingTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. M.D. Bulent Haydardedeoglu

Study Record Dates

First Submitted

February 11, 2015

First Posted

March 18, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 2, 2018

Record last verified: 2015-03

Locations

TU(1)