Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization

NCT ID: NCT03831542

Last Updated: 2019-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-19

Study Completion Date

2019-05-06

Brief Summary

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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.

Detailed Description

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Oocyte retrieval procedure This study aims to evaluate the effect of follicular flushing during oocyte retrieval procedure in patients with only one follicle. Double lumen needle will be used and direct follicular aspiration without flushing will be performed for all patients. If an oocyte will be obtained, the patient will be assigned to group A. If not, at least 1 course of follicular flushing will be used until retrieval of an oocyte and the patient will be assigned to group B.

Conditions

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Invitro Fertilization Diminished Ovarian Reserve Oocyte

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

direct follicular aspiration

Intervention Type 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.

follicular flushing

Intervention Type BEHAVIORAL

follicular flushing

Interventions

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direct follicular aspiration

direct follicular aspiration

Intervention Type BEHAVIORAL

follicular flushing

follicular flushing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centrum Clinic IVF Center

OTHER

Sponsor Role lead

Responsible Party

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Emre Göksan Pabuçcu

Emre G. Pabuccu, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emre Pabuccu, MD

Role: STUDY_DIRECTOR

Centrum Clinic IVF Center

Locations

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Centrum Clinic IVF Center

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 28333185 (View on PubMed)

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.

Reference Type RESULT
PMID: 28276148 (View on PubMed)

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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