NCT03831542

Brief Summary

Retrieval of an oocyte from a follicle relies on the release of the cumulus-oocyte-complex (COC) from the follicular wall into the lumen, thereby allowing aspiration by a needle. Flushing the follicle with multiple aspirations from the same follicle is used as a means to increase the ratio of COC per aspirated follicle. Data showed that follicular flushing is not superior to direct aspiration either in normally responding patients or in poor responders undergoing in vitro fertilization (IVF). There is no data in the literature regarding the issue in patients with mono-follicular growth. Direct aspiration or repeatedly flushing the follicle for those with a single follicle will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 6, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

February 19, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

February 2, 2019

Last Update Submit

May 6, 2019

Conditions

Invitro FertilizationDiminished Ovarian ReserveOocyte

Keywords

follicular flushingdouble lumen needle

Outcome Measures

Primary Outcomes (1)

  • mature oocyte

    Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.

    during oocyte retrieval procedure

Secondary Outcomes (2)

  • fertilization rate after micro-injection

    24 hours after microinjection procedure

  • clinical pregnancy rate per embryo transfer

    untill 6 weeks

Study Arms (2)

direct aspiration group

Transvaginal ultrasound-guided oocyte retrieval was performed 36 hours after ovulation trigger. A 17-gauge double lumen needle will be used to aspirate a single follicle without flushing. If an oocyte is obtained, the subject will be assigned to group 1. If not, operator will proceed with follicular flushing.

Behavioral: direct follicular aspiration

flushing group

If an oocyte is not obtained with direct aspiration, operator will proceed to follicular flushing and the subject will be assigned to group 2 if an oocyte is obtained following follicular flushing.

Behavioral: follicular flushing

Interventions

direct follicular aspirationBEHAVIORAL

direct follicular aspiration

direct aspiration group
follicular flushingBEHAVIORAL

follicular flushing

flushing group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women undergoing oocyte retrieval procedure due to primary infertility

You may qualify if:

  • women aged 18-40 years
  • primary infertility
  • diminished ovarian reserve with single mature follicle on the day of oocyte retrieval

You may not qualify if:

  • natural cycle IVF
  • presence of endometriosis/endometrioma(s)
  • Absence of cumulus oocyte complex following oocyte retrieval
  • Severe male factor infertility
  • Pre-implantation genetic screening cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Clinic IVF Center

Ankara, 06700, Turkey (Türkiye)

Location

Related Publications (2)

  • von Horn K, Depenbusch M, Schultze-Mosgau A, Griesinger G. Randomized, open trial comparing a modified double-lumen needle follicular flushing system with a single-lumen aspiration needle in IVF patients with poor ovarian response. Hum Reprod. 2017 Apr 1;32(4):832-835. doi: 10.1093/humrep/dex019.

    PMID: 28333185BACKGROUND

  • Haydardedeoglu B, Gjemalaj F, Aytac PC, Kilicdag EB. Direct aspiration versus follicular flushing in poor responders undergoing intracytoplasmic sperm injection: a randomised controlled trial. BJOG. 2017 Jul;124(8):1190-1196. doi: 10.1111/1471-0528.14629. Epub 2017 May 2.

    PMID: 28276148RESULT

Study Officials

  • Emre Pabuccu, MD

    Centrum Clinic IVF Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Emre G. Pabuccu, Assoc. Prof.

Study Record Dates

First Submitted

February 2, 2019

First Posted

February 6, 2019

Study Start

February 19, 2019

Primary Completion

May 5, 2019

Study Completion

May 6, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

TU(1)