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Influence of FSH/LH Ratio in Controlled Ovarian Stimulation

Primary Purpose

Sub-Fertility

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
FSH/LH
Sponsored by
Hospital de Cruces
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sub-Fertility focused on measuring FSH, LH, IVF

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing IVF cycles in Cruces University Hospital.
  • Signed IVF and cryopreservation informed consent.
  • Age >35 and <40 years.
  • FSH levels <10 mIU/ml.

Exclusion Criteria:

  • When inclusion criteria are not fulfilled

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    FSH/LH 2/1

    FSH/LH 4/1

    Arm Description

    dose: 300IU FSHrec and 150IU LHrec

    dose: 300IU FSHrec and 75IU LHrec

    Outcomes

    Primary Outcome Measures

    Pregnancy achievement
    To report our results in terms of pregnancy per embryo transfer

    Secondary Outcome Measures

    Full Information

    First Posted
    December 1, 2016
    Last Updated
    August 2, 2022
    Sponsor
    Hospital de Cruces
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02994550
    Brief Title
    Influence of FSH/LH Ratio in Controlled Ovarian Stimulation
    Official Title
    Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in >35 Years Women Undergoing IVF
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital de Cruces

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sub-Fertility
    Keywords
    FSH, LH, IVF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    447 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FSH/LH 2/1
    Arm Type
    Experimental
    Arm Description
    dose: 300IU FSHrec and 150IU LHrec
    Arm Title
    FSH/LH 4/1
    Arm Type
    Experimental
    Arm Description
    dose: 300IU FSHrec and 75IU LHrec
    Intervention Type
    Drug
    Intervention Name(s)
    FSH/LH
    Primary Outcome Measure Information:
    Title
    Pregnancy achievement
    Description
    To report our results in terms of pregnancy per embryo transfer
    Time Frame
    3 months after drug administration

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients undergoing IVF cycles in Cruces University Hospital. Signed IVF and cryopreservation informed consent. Age >35 and <40 years. FSH levels <10 mIU/ml. Exclusion Criteria: When inclusion criteria are not fulfilled

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Influence of FSH/LH Ratio in Controlled Ovarian Stimulation

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