NCT05130125

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,166

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 23, 2023

Status Verified

November 1, 2021

Enrollment Period

1.3 years

First QC Date

November 4, 2021

Last Update Submit

August 21, 2023

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Number of Oocytes

    Counting number of Oocytes

    average of 14 days

Study Arms (2)

fresh embryo

fresh embryo transfer after ovarian hyperstimulation

Drug: rFSH

frozen embryo

frozen embryo transfer after ovarian hyperstimulation

Drug: rFSH

Interventions

rFSHDRUG

rFSH or HP-hMG or rFSH and HP-hMG

Also known as: HP-hMG, rFSH and HP-hMG
fresh embryofrozen embryo

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

infertile female patients

You may qualify if:

  • First IVF-ET cycle patients

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Fertility Hospital

Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Jieun Shin

    Cha medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2021

First Posted

November 22, 2021

Study Start

September 14, 2021

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

August 23, 2023

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)