Infertility, FemaleNCT05130125
Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer
An observational study of Infertility, Female, run by LG Chem at 1 site in South Korea.
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) Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- rFSH
- How many people
- 1,166 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Sep 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: infertile female patients
Who may be able to join
- First IVF-ET cycle patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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)
Read the 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
- Conditions
- Infertility, Female
- Being tested
- rFSH
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rFSHDrug
Also called HP-hMG, rFSH and HP-hMG
rFSH or HP-hMG or rFSH and HP-hMG
| Study group | Role | What they receive |
|---|---|---|
| fresh embryo | fresh embryo transfer after ovarian hyperstimulation Receives: Drug: rFSH | |
| frozen embryo | frozen embryo transfer after ovarian hyperstimulation Receives: Drug: rFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes
Counting number of Oocytes
Measured: average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start14 Sep 2021
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jieun Shin, Principal investigator, Cha medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130125
- Sponsor's protocol ID
- LG-IMHOS001
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05130125
- Acronym / sponsor ID
- LG-IMHOS001
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh embryo | – | Drug: rFSHfresh embryo transfer after ovarian hyperstimulation |
| frozen embryo | – | Drug: rFSHfrozen embryo transfer after ovarian hyperstimulation |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- infertile female patients
Key inclusion criteria (1 listed)
- First IVF-ET cycle patients
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rFSHAlso: HP-hMG, rFSH and HP-hMGrFSH or HP-hMG or rFSH and HP-hMG | Drug | fresh embryo, frozen embryo |
Primary outcome
Number of Oocytes
Time frame: average of 14 days
Counting number of Oocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Infertility, Female
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieun Shin principal investigator
Cha medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by LG Chem at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Oocytes (time frame: average of 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.