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NCT05130125 Clinical Trial

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

Infertility, Female Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05130125
Other study ID # LG-IMHOS001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 14, 2021
Est. completion date June 30, 2023

Study information
Verified date November 2021
Source LG Chem
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

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

Recruitment information / eligibility
Status Completed
Enrollment 1166
Est. completion date June 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 39 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of CHA Fertility Hospital Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
LG Chem

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Oocytes Counting number of Oocytes average of 14 days
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