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

May 6, 2019 updated by: Emre Göksan Pabuçcu, Centrum Clinic IVF Center

Follicular Flushing in Patients With Mono-follicular Growth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06700
        • Centrum Clinic IVF Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women undergoing oocyte retrieval procedure due to primary infertility

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mature oocyte
Time Frame: during oocyte retrieval procedure
Confirmation of cumulus oocyte complex (COC) after microscopic examination of follicular fluid by a senior embryologist for each patient.
during oocyte retrieval procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centrum Clinic IVF Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 19, 2019

Primary Completion (ACTUAL)

May 5, 2019

Study Completion (ACTUAL)

May 6, 2019

Study Registration Dates

First Submitted

February 2, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 6, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diminished Ovarian Reserve

Clinical Trials on direct follicular aspiration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe