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GnRH Agonist as Luteal Support in FET Cycles

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Natural cycle: Triptorelin acetate 0.1 mg
Hormone replacement cycle and triptorelin acetate 0.1 mg
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 20 - 45 year old women comig to frozen thawed embryo transfer

Exclusion Criteria:

  • The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive
  • Abnormal uterus
  • Known abnormality of karyotype of the woman or her partner
  • Severe male factor as an exclusive reason for subfertility
  • Allegy for triptorelin acetate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    No Intervention

    Experimental

    Arm Label

    Natural cycle, control

    Natural cycle, intervention

    Hormone replacement cycle, control

    Hormone replacement cycle, intervention

    Arm Description

    Treatment cycles with normal luteal support with progesteron

    Treatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence.

    Standard hormone replacement cycle with estrogen and progesteron

    Standard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days

    Outcomes

    Primary Outcome Measures

    Pregnancy rate
    Implantation rate
    Ongoing pregnancy rate

    Secondary Outcome Measures

    hCG- level

    Full Information

    First Posted
    November 30, 2015
    Last Updated
    November 22, 2016
    Sponsor
    Turku University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02620124
    Brief Title
    GnRH Agonist as Luteal Support in FET Cycles
    Official Title
    GnRH Anonist as Luteal Support in Frozen-thawed Embryo Transfer Cycles
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    October 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Turku University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported. Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Natural cycle, control
    Arm Type
    No Intervention
    Arm Description
    Treatment cycles with normal luteal support with progesteron
    Arm Title
    Natural cycle, intervention
    Arm Type
    Experimental
    Arm Description
    Treatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence.
    Arm Title
    Hormone replacement cycle, control
    Arm Type
    No Intervention
    Arm Description
    Standard hormone replacement cycle with estrogen and progesteron
    Arm Title
    Hormone replacement cycle, intervention
    Arm Type
    Experimental
    Arm Description
    Standard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days
    Intervention Type
    Drug
    Intervention Name(s)
    Natural cycle: Triptorelin acetate 0.1 mg
    Intervention Description
    A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
    Intervention Type
    Drug
    Intervention Name(s)
    Hormone replacement cycle and triptorelin acetate 0.1 mg
    Intervention Description
    A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support
    Primary Outcome Measure Information:
    Title
    Pregnancy rate
    Time Frame
    five weeks after the embryo transfer
    Title
    Implantation rate
    Time Frame
    five weeks after the embryo transfer
    Title
    Ongoing pregnancy rate
    Time Frame
    ten weeks after the embryo transfer
    Secondary Outcome Measure Information:
    Title
    hCG- level
    Time Frame
    14 days after thawing of the embryos

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 20 - 45 year old women comig to frozen thawed embryo transfer Exclusion Criteria: The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive Abnormal uterus Known abnormality of karyotype of the woman or her partner Severe male factor as an exclusive reason for subfertility Allegy for triptorelin acetate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Varpu Jokimaa, MD, PhD
    Organizational Affiliation
    Hospital District of the South-West Finland
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    GnRH Agonist as Luteal Support in FET Cycles

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