search
Back to results

The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle Counseling
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polycystic Ovary Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of PCOS
  • Long schedule time of Luteal phase
  • Available to trace
  • Normal Prolactin level with contraceptive treatment in recent 3 months

Exclusion Criteria:

  • Unwilling to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Lifestyle counseling

    No treatment

    Arm Description

    The investigators use several methods to educate patients of controllable factors like lifestyle counseling, and monitor the factors like BMI and other index until the statistics become normal.

    Patients without any intervention and still have abnormal factors like BMI, etc.

    Outcomes

    Primary Outcome Measures

    oocyte number
    Affect the outcome of IVF-ET treatment

    Secondary Outcome Measures

    Success Rate
    The success rate of IVF-ET treatment elevated
    OHSS complication
    The number of OHSS patients reduced

    Full Information

    First Posted
    December 31, 2014
    Last Updated
    January 2, 2015
    Sponsor
    Peking University Third Hospital
    Collaborators
    Beijing University Health Science Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02331758
    Brief Title
    The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment
    Official Title
    The Influence Factors of Ovarian Response in Polycystic Ovary Syndrome Patients(PCOS) With In Vitro Fertilization and Embryo Transfer (IVF-ET) Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    September 2015 (Anticipated)
    Study Completion Date
    September 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital
    Collaborators
    Beijing University Health Science Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to explore the factors which affect ovarian response of PCOS patients with IVF-ET treatment, in order to provide predictive clinical index for the outcome of IVF-ET treatment in PCOS patients. After figuring out the controllable factors, researchers would be able to educate PCOS patients and improve the success rate while reducing the incidence of complications during the treatment at the same time.
    Detailed Description
    Statistics of PCOS patients like age, BMI index and others would be collected. Through distributing questionnaires and query of past cases and collecting data recorded during the ovulation process like monitoring fluctuations in blood and ultrasonic monitoring results, researchers obtain the risk factors of the occurence of Ovarian Hyperstimulation Syndrome(OHSS) in IVF-ET treatment in PCOS patients and set up an OHSS prediction model, choose controllable factors in order to make up guidance and have intervention on patients with PCOS accordingly. The investigators expect this could improve the success rate of IVF-ET treatment in patients with PCOS, provide clues and assist to reduce the risk of the therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle counseling
    Arm Type
    Experimental
    Arm Description
    The investigators use several methods to educate patients of controllable factors like lifestyle counseling, and monitor the factors like BMI and other index until the statistics become normal.
    Arm Title
    No treatment
    Arm Type
    No Intervention
    Arm Description
    Patients without any intervention and still have abnormal factors like BMI, etc.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle Counseling
    Intervention Description
    The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.
    Primary Outcome Measure Information:
    Title
    oocyte number
    Description
    Affect the outcome of IVF-ET treatment
    Time Frame
    3 Month
    Secondary Outcome Measure Information:
    Title
    Success Rate
    Description
    The success rate of IVF-ET treatment elevated
    Time Frame
    3 Month
    Title
    OHSS complication
    Description
    The number of OHSS patients reduced
    Time Frame
    3 Month

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of PCOS Long schedule time of Luteal phase Available to trace Normal Prolactin level with contraceptive treatment in recent 3 months Exclusion Criteria: Unwilling to participate

    12. IPD Sharing Statement

    Learn more about this trial

    The Influence Factors of Ovarian Response in PCOS Patients With IVF-ET Treatment

    We'll reach out to this number within 24 hrs