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Completed

NCT Number: NCT03831542

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

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.

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Key information

Conditions

Invitro Fertilization Diminished Ovarian Reserve Oocyte

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Centrum Clinic IVF Center

Ankara, 06700, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

direct follicular aspiration

Behavioral

direct follicular aspiration

follicular flushing

Behavioral

follicular flushing

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Centrum Clinic IVF Center

Other

Registry information

Official study title

Follicular Flushing in Patients With Mono-follicular Growth

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 6, 2019
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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