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

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)

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)

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: rFSH

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 Type: Observational
• Enrollment (Actual): 1166

Contacts and Locations

• Study Contact: Name: Yujung Lee; Phone Number: 82-26987-4287; Email: yujunglee@lgchem.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
    • CHA Fertility Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

infertile female patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oocytes	Counting number of Oocytes	average of 14 days

Collaborators and Investigators

• Sponsor: LG Chem
• Investigators: Principal Investigator: Jieun Shin, CHA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: November 4, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: LG-IMHOS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No