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

Sponsor

Centrum Clinic IVF Center (Other)

Overall Status

Completed

CT.gov ID

NCT03831542

Collaborator

(none)

Enrollment

Location

2.5

Actual Duration (Months)

28.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Invitro Fertilization Diminished Ovarian Reserve Oocyte	Behavioral: direct follicular aspiration Behavioral: follicular flushing

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

71 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Follicular Flushing in Patients With Mono-follicular Growth

Actual Study Start Date :

Feb 19, 2019

Actual Primary Completion Date :

May 5, 2019

Actual Study Completion Date :

May 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
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 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 follicular flushing

Arm

Intervention/Treatment

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

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

follicular flushing

Outcome Measures

Primary Outcome Measures

mature oocyte [during oocyte retrieval procedure]
Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.

Secondary Outcome Measures

fertilization rate after micro-injection [24 hours after microinjection procedure]
Confirmation of pronuclei formation on the following day of microinjection by a senior embryologist in each patient.
clinical pregnancy rate per embryo transfer [untill 6 weeks]
Confirmation of fetal cardiac activity on 5th or 6th week of gestation by a senior obstetrician in each pregnancy case.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centrum Clinic IVF Center	Ankara		Turkey	06700

Sponsors and Collaborators

Centrum Clinic IVF Center

Investigators

Study Director: Emre Pabuccu, MD, Centrum Clinic IVF Center

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Emre Göksan Pabuçcu, Emre G. Pabuccu, Assoc. Prof., Centrum Clinic IVF Center

ClinicalTrials.gov Identifier:

NCT03831542

Other Study ID Numbers:

First Posted:

Feb 6, 2019

Last Update Posted:

May 7, 2019

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Emre Göksan Pabuçcu, Emre G. Pabuccu, Assoc. Prof., Centrum Clinic IVF Center

follicular flushing

double lumen needle

Additional relevant MeSH terms:

Flushing

Study Results

No Results Posted as of May 7, 2019