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Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer

Sponsor
LG Chem (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05130125
Collaborator
(none)
1,500
Enrollment
1
Location
20.5
Anticipated Duration (Months)
73.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG)

Condition or Disease Intervention/Treatment Phase

Detailed Description

A multicenter, retrospective cohort observational study to evaluate the effectiveness and safety of fresh or frozen embryo transfer after ovarian hyperstimulation (administration of rFSH or HP-hMG alone or co-administration of rFSH and HP-hMG) to infertile female patients undergoing assisted reproductive technology to controlled ovarian hyperstimulation

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer After Ovarian Hyperstimulation (Administration of rFSH or HP-hMG Alone or Co-administration of rFSH and HP-hMG)
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
fresh embryo

fresh embryo transfer after ovarian hyperstimulation

Drug: rFSH
rFSH or HP-hMG or rFSH and HP-hMG
Other Names:
  • HP-hMG
  • rFSH and HP-hMG

    		•
    frozen embryo

    frozen embryo transfer after ovarian hyperstimulation

    Drug: rFSH
    rFSH or HP-hMG or rFSH and HP-hMG
    Other Names:
  • HP-hMG
  • rFSH and HP-hMG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Oocytes [average of 14 days]

      Counting number of Oocytes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • First IVF-ET cycle patients
    Exclusion Criteria:

    Poor ovarian responder

    • At least two of the following three features must be present: (i) Advanced maternal age (≥ 40 years) or any other risk factor for Poor ovarian response (POR); (ii) A previous POR (≤ 3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5-1.1 ng/mL)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHA Fertility Hospital Gyeonggi-do Korea, Republic of

    Sponsors and Collaborators

    • LG Chem

    Investigators

    • Principal Investigator: Jieun Shin, Cha medical center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LG Chem
    ClinicalTrials.gov Identifier:
    NCT05130125
    Other Study ID Numbers:
    • LG-IMHOS001
    First Posted:
    Nov 22, 2021
    Last Update Posted:
    Nov 22, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female

    Study Results

    No Results Posted as of Nov 22, 2021