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Follicular Flushing Versus Direct Aspiration

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ClinicalTrials.gov Identifier: NCT03354858
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : July 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eugonia

Brief Summary:
The purpose of this study is to investigate the impact of follicular flushing on the oocyte recovery rate, oocyte maturity, fertilization rate, and embryo development and utilization as compared to direct aspiration (no flushing) in women undergoing IVF treatment

Condition or disease Intervention/treatment
Infertility Procedure: Follicular flushing

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oocyte Recovery Rate Following Follicular Flushing Versus Direct Aspiration in Women Undergoing IVF
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : June 1, 2018

Group/Cohort Intervention/treatment
Follicular flushing
One ovary will be aspirated using follicular flushing (up to 5 times per follicle).
Procedure: Follicular flushing
Repeated follicle flushing up to 5 times using a double lumen needle for oocyte recovery

No flushing
One ovary will be aspirated using direct aspiration (no flushing).



Primary Outcome Measures :
  1. Oocyte recovery rate [ Time Frame: Day of oocyte retrieval ]
    Number of oocytes retrieved per follicle aspirated


Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval ]
    Number of oocytes retrieved

  2. Oocyte maturation rate [ Time Frame: Day of oocyte retrieval ]
    Number of mature (metaphase-II) oocytes per oocyte retrieved

  3. Fertilization rate [ Time Frame: Day 1 post oocyte retrieval ]
    Number of fertilized oocytes per oocyte injected/inseminated

  4. Good quality embryos on day 2/3 [ Time Frame: 2/3 days post oocyte retrieval ]
    Percentage of good quality embryos per number of fertilized oocytes

  5. Blastocyst formation rates [ Time Frame: Day 5 post oocyte retrieval ]
    Number of blastocysts formed on Day 5 per number of fertilized oocytes

  6. Hemorrhage [ Time Frame: Day of oocyte retrieval ]
    Hemorrhagic ovary during/following oocyte retrieval

  7. Embryo cryopreservation [ Time Frame: Day 5 post oocyte retrieval ]
    Number of embryos cryopreserved per total number of fertilized oocytes

  8. Embryo utilization [ Time Frame: Day 5 post oocyte retrieval ]
    Number of embryos transferred and cryopreserved per total number of fertilized oocytes

  9. Embryos transferred [ Time Frame: Days 2-5 post oocyte retrieval ]
    Number of embryos selected for transfer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must be born as females and have two ovaries present
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women undergoing IVF treatment
Criteria

Inclusion Criteria:

  • Presence of both ovaries
  • 18-40 years old
  • Triggering final oocyte maturation using human chorionic gonadotrophin (hCG) or gonadotrophin releasing hormone (GnRH) agonist

Exclusion Criteria:

  • One or no ovaries present
  • Endometriosis
  • Previous history of hemorrhage during oocyte retrieval

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354858


Locations
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Greece
Eugonia
Athens, Greece, 11528
Sponsors and Collaborators
Eugonia
Investigators
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Study Director: Lainas, PhD Eugonia
Publications:
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Responsible Party: Eugonia
ClinicalTrials.gov Identifier: NCT03354858    
Other Study ID Numbers: Follicular flushing
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eugonia:
follicle flushing
direct follicle aspiration
fertilization rate
maturation
Additional relevant MeSH terms:
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Infertility
Flushing
Genital Diseases, Male
Genital Diseases, Female
Skin Manifestations
Signs and Symptoms