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CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage (MELISSA)

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cryopreservation of embryos at cleavage stage
cryopreservation of embryos at blastocyst stage
Sponsored by
Université Libre de Bruxelles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring OHSS, Agonist trigger, freeze-all, blastocyst, cleavage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients <40 years old
  • Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI)
  • No more than 2 previous failed IVF/ICSI cycles
  • Stimulation in GnRH antagonist cycle
  • Presence of ≥16 follicles of >10mm on the day of triggering of final oocyte maturation
  • GnRH agonist trigger (triptorelin 0.2mg)

Exclusion Criteria:

  • Cycles with testicular sperm extraction
  • Preimplantation genetic diagnosis
  • Patients with uterine malformations
  • Patients with infectious diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Cleavage

    Blastocyst

    Arm Description

    Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development

    Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)

    Outcomes

    Primary Outcome Measures

    Cumulative live birth
    Cumulative live birth rate per oocyte retrieval

    Secondary Outcome Measures

    Frozen thawed embryo transfer cycles needed to achieve live birth
    Number of frozen thawed embryo transfer cycles needed to achieve live birth

    Full Information

    First Posted
    December 7, 2018
    Last Updated
    January 23, 2019
    Sponsor
    Université Libre de Bruxelles
    Collaborators
    Aristotle University Of Thessaloniki
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03817060
    Brief Title
    CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage
    Acronym
    MELISSA
    Official Title
    CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage in a Single Embryo Transfer Setting (MELISSA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    February 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Université Libre de Bruxelles
    Collaborators
    Aristotle University Of Thessaloniki

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Ovarian stimulation for the induction of multifollicular growth by gonadotrophins represents an important part of In Vitro Fertilization (IVF). However, the use of these drugs can be associated with side effects, from which the most common is the Ovarian Hyperstimulation Syndrome (OHSS). Stimulation with gonadotrophins in a Gonadotropin-releasing hormone (GnRH) antagonist cycle rather than a GnRH agonist cycle reduces significantly the risk of OHSS. During stimulation, the best predictor of severe OHSS is the number of follicles >10mm on the day of triggering final oocyte maturation, with the threshold at ≥16 follicles. When this occurs, final oocyte maturation can be induced with a GnRH agonist, reducing further the risk the syndrome. To perform a fresh embryo transfer, 1500 IU human Chorionic Gonadotropin (hCG) can be administered on the day of oocyte retrieval for the luteal support. However, with this procedure there are still some cases of OHSS. To overcome this, it is suggested to combine GnRH agonist triggering with a freeze-all embryos strategy and perform embryo replacement in subsequent frozen-thawed embryo transfer (FET) cycles. Different cryopreservation strategies are been performed according to the procedure of each fertility center, such as cryopreservation at 2 pronuclear (2PN), cleavage or blastocyst stage. The aim of this study is to determine the optimal strategy for the freeze-all cycles and particularly the optimal day for freezing, thawing and transferring the embryos. The hypothesis is that there will increased cumulative live birth rates per started cycle in blastocyst compared to cleavage stage FET cycles.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility
    Keywords
    OHSS, Agonist trigger, freeze-all, blastocyst, cleavage

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    128 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cleavage
    Arm Type
    Active Comparator
    Arm Description
    Embryos cryopreserved with vitrification at the cleavage stage (day 3) of embryo development
    Arm Title
    Blastocyst
    Arm Type
    Active Comparator
    Arm Description
    Embryos cryopreserved with vitrification at the blastocyst stage (day 5 or 6)
    Intervention Type
    Procedure
    Intervention Name(s)
    cryopreservation of embryos at cleavage stage
    Intervention Description
    cryopreservation of embryos at cleavage stage (day 3) of embryo development
    Intervention Type
    Procedure
    Intervention Name(s)
    cryopreservation of embryos at blastocyst stage
    Intervention Description
    cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development
    Primary Outcome Measure Information:
    Title
    Cumulative live birth
    Description
    Cumulative live birth rate per oocyte retrieval
    Time Frame
    within one year of randomisation
    Secondary Outcome Measure Information:
    Title
    Frozen thawed embryo transfer cycles needed to achieve live birth
    Description
    Number of frozen thawed embryo transfer cycles needed to achieve live birth
    Time Frame
    within one year of randomisation

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients <40 years old Indication for In Vitro Fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) No more than 2 previous failed IVF/ICSI cycles Stimulation in GnRH antagonist cycle Presence of ≥16 follicles of >10mm on the day of triggering of final oocyte maturation GnRH agonist trigger (triptorelin 0.2mg) Exclusion Criteria: Cycles with testicular sperm extraction Preimplantation genetic diagnosis Patients with uterine malformations Patients with infectious diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Theoni Tarlatzi
    Phone
    +3225558948
    Email
    nonika.tarlatzi@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    CuMulativE Live bIrth Rate of Patients at High Risk of OHSS After Freeze-all Embryos at Cleavage or blAstocyst Stage

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