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

NCT ID: NCT05130125

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1166 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-14

Study Completion Date

2023-06-30

Brief Summary

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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)

Detailed Description

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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

Conditions

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Infertility, Female

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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fresh embryo

fresh embryo transfer after ovarian hyperstimulation

rFSH

Intervention Type DRUG

rFSH or HP-hMG or rFSH and HP-hMG

frozen embryo

frozen embryo transfer after ovarian hyperstimulation

rFSH

Intervention Type DRUG

rFSH or HP-hMG or rFSH and HP-hMG

Interventions

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rFSH

rFSH or HP-hMG or rFSH and HP-hMG

Intervention Type DRUG

Other Intervention Names

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HP-hMG rFSH and HP-hMG

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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LG Chem

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jieun Shin

Role: PRINCIPAL_INVESTIGATOR

Cha medical center

Locations

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CHA Fertility Hospital

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LG-IMHOS001

Identifier Type: -

Identifier Source: org_study_id

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