search
Back to results

Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS) (LEFT)

Primary Purpose

Infertility, Female, Polycystic Ovary Syndrome, IVF

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Letrozole
estradiol valerate
Sponsored by
CRG UZ Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring frozen embryo transfer

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age more than or equal to 18 and less than or equal to 40
  • BMI more than or equal to 18 and less than or equal to 35
  • Diagnosis of PCOS according to Rotterdam criteria
  • Normal gynaecological ultrasound < 6 months before inclusion
  • Signed informed consent form
  • Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage

Exclusion Criteria:

  • Recurrent implantation failure
  • Recurrent miscarriage
  • Presence of adenomyosis
  • Untreated intrauterine pathology
  • rAFS (revised American Fertility Society) Grade III or IV endometriosis
  • Hydrosalpinx
  • In vitro maturation (IVM)
  • Untreated autoimmune disorders
  • (History of) malignancy
  • Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past
  • Pre-implantation genetic testing (PGT)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Hormonal Replacement Therapy

    Letrozole

    Arm Description

    Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.

    Using letrozole for ovulation induction before planning the frozen embryo transfer

    Outcomes

    Primary Outcome Measures

    early pregnancy loss

    Secondary Outcome Measures

    cancellation rate
    number of visits to the clinic
    endometrial thickness on the day of planning of FET
    implantation rate
    biochemical and clinical pregnancy rate
    live birth rate
    neonatal birth weight
    term of delivery
    hypertensive disorders of pregnancy

    Full Information

    First Posted
    June 27, 2019
    Last Updated
    January 6, 2021
    Sponsor
    CRG UZ Brussel
    Collaborators
    University Hospital, Ghent
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04002635
    Brief Title
    Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)
    Acronym
    LEFT
    Official Title
    Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Practical issues
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    April 1, 2021 (Anticipated)
    Study Completion Date
    April 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CRG UZ Brussel
    Collaborators
    University Hospital, Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    To offer patients with oligomenorrhoea or amenorrhoea an alternative to frozen embryo transfer in an artificial cycle, endometrial preparation using letrozole may be a valuable option. Letrozole, a potent, reversible nonsteroidal aromatase inhibitor with relatively short half-life, can successfully induce ovulation without any adverse anti-estrogenic effects and thus without affecting the endometrium. The use of letrozole typically results in monofollicular growth and this reduces the effect of supraphysiological levels of estrogen on the endometrium and embryo. The purpose of this study is to compare a frozen-thawed embryo transfer in an artificial cycle with a letrozole-induced ovulatory cycle, specifically in PCOS patients. The primary outcome is early pregnancy loss.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility, Female, Polycystic Ovary Syndrome, IVF, Ovulation Disorder
    Keywords
    frozen embryo transfer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Hormonal Replacement Therapy
    Arm Type
    Active Comparator
    Arm Description
    Artificial preparation of the endometrium using estradiol valerate 2mg 3x/day, and vaginal micronized progesterone 2x 400mg/day.
    Arm Title
    Letrozole
    Arm Type
    Experimental
    Arm Description
    Using letrozole for ovulation induction before planning the frozen embryo transfer
    Intervention Type
    Drug
    Intervention Name(s)
    Letrozole
    Intervention Description
    Letrozole ovulation induction
    Intervention Type
    Drug
    Intervention Name(s)
    estradiol valerate
    Other Intervention Name(s)
    progesterone
    Intervention Description
    hormonal replacement therapy
    Primary Outcome Measure Information:
    Title
    early pregnancy loss
    Time Frame
    12 weeks after frozen embryo transfer
    Secondary Outcome Measure Information:
    Title
    cancellation rate
    Time Frame
    2 months
    Title
    number of visits to the clinic
    Time Frame
    2 months
    Title
    endometrial thickness on the day of planning of FET
    Time Frame
    1 day
    Title
    implantation rate
    Time Frame
    1 day
    Title
    biochemical and clinical pregnancy rate
    Time Frame
    12 weeks
    Title
    live birth rate
    Time Frame
    1 year
    Title
    neonatal birth weight
    Time Frame
    1 year
    Title
    term of delivery
    Time Frame
    1 year
    Title
    hypertensive disorders of pregnancy
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age more than or equal to 18 and less than or equal to 40 BMI more than or equal to 18 and less than or equal to 35 Diagnosis of PCOS according to Rotterdam criteria Normal gynaecological ultrasound < 6 months before inclusion Signed informed consent form Day 5 or 6 frozen-thawed embryo transfer, blastocyst stage Exclusion Criteria: Recurrent implantation failure Recurrent miscarriage Presence of adenomyosis Untreated intrauterine pathology rAFS (revised American Fertility Society) Grade III or IV endometriosis Hydrosalpinx In vitro maturation (IVM) Untreated autoimmune disorders (History of) malignancy Allergy or reaction to the use of progynova, utrogestan and/or letrozole in the past Pre-implantation genetic testing (PGT)

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Sharing with other study site, UZ Gent

    Learn more about this trial

    Letrozole for Frozen Embryo Transfer (FET) in Patients With Polycystic Ovary Syndrome (PCOS)

    We'll reach out to this number within 24 hrs