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There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?

Primary Purpose

Female Infertility

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
LH value
Sponsored by
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Female Infertility

Eligibility Criteria

35 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 1) age <39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels < 12 IU/ml; (4) body mass index (BMI) between 18-30 Kg/m2; (5) no oral contraceptive pills taken in the last year

Exclusion Criteria:

  • polycystic ovaries, age >39 years

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    LH value in fixed group

    LH value in flexible group

    Arm Description

    LH value predictive of IVF in 104 patients entered in fixed protocol

    LH value predictive of IVF in 109 patients entered in flexible protocols

    Outcomes

    Primary Outcome Measures

    number of mature oocytes recruited after IVF with antagonist protocol

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2014
    Last Updated
    December 29, 2014
    Sponsor
    U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02328924
    Brief Title
    There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?
    Official Title
    There is a Cut Off Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome? A Randomized Controlled Trial in Fixed Versus Flexible Gonadotropin-releasing Hormone Antagonist Protocols.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study, prospective randomized controlled trial, tried to identify a cut off value of luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible gonadotropin-releasing hormone antagonist protocols. 202 norma-ovulatory women < 39 years were randomized to fixed or flexible group in GnRH antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and progesterone in the two study groups was measured. Total number of retrieved oocytes, implantation and pregnancy rate were recorded. .

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    LH value in fixed group
    Arm Type
    Other
    Arm Description
    LH value predictive of IVF in 104 patients entered in fixed protocol
    Arm Title
    LH value in flexible group
    Arm Type
    Other
    Arm Description
    LH value predictive of IVF in 109 patients entered in flexible protocols
    Intervention Type
    Other
    Intervention Name(s)
    LH value
    Intervention Description
    analyzed LH value in the the arms of the study, fixed and flexible protocols
    Primary Outcome Measure Information:
    Title
    number of mature oocytes recruited after IVF with antagonist protocol
    Time Frame
    partecipant will be followed for the duration of the cycle of IVF and for the following three months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1) age <39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels < 12 IU/ml; (4) body mass index (BMI) between 18-30 Kg/m2; (5) no oral contraceptive pills taken in the last year Exclusion Criteria: polycystic ovaries, age >39 years

    12. IPD Sharing Statement

    Learn more about this trial

    There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?

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