Infertility, FemaleNCT03317548
A Comparison of Clinical Outcomes of Warmed Embryo Vitrified at 2PN Stage and Fresh Embryo Transfers
An observational study of Infertility, Female and Reproductive Disorder, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer. This is a retrospective study. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Reproductive Disorder
- What is being tested?
- progesterone and day 3 embryo
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2017to 30 Apr 2018
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: all patients underwent in vitro fertilization protocols in Lee Women's Hospital
Who may be able to join
- all patients with in vitro fertilization protocols
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung, 40201
886-4-24739595 ext. 21737, irb@csh.gov.tw
About this study
Official title: Chung Shan Medical University Hospital
The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer.
This is a retrospective study. All IVF cycles were included in this study and further divided into fresh and frozen embryo transfer groups. The collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. The primary outcome is pregnancy rate and secondary outcome is implantation rate.
Read the detailed description
Study design
Study progress:
Stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups.
Stage 2: selection data and check the delivery outcomes Stage 3: analysis data and presentation. Including criteria: all patients who underwent IVF. Excluding criteria: No. Statistics analysis: chi-test, t-test
Assessment point:
Primary endpoint: pregnancy rate Secondary endpoint: implantation rate Withdraw criteria: not application. Treatments: not application. Collection number: 500 patients. Scheduled trial period: 2017.05.01~2018.04.30
Expected research results:
The implantation rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.
The pregnancy rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.
This study is only data analysis, no additional collection of samples. This study does not involve vulnerable groups.
- Conditions
- Infertility, Female, Reproductive Disorder
- Being tested
- progesterone, day 3 embryo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesteroneDiagnostic test
according progesterone level to decide fresh or frozen embryo transfer
day 3 embryoDiagnostic test
according day 3 embryo to decide fresh or frozen embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| fresh embryo transfer | patients with fresh day 3 embryo transfer after oocyte pick up, the hormone including FSH, LH, E2 and progesterone was test before embryo transfer for analysis. The clinical outcomes including implantation and pregnancy were checked and recorded. Receives: Diagnostic Test: progesterone; Diagnostic Test: day 3 embryo | |
| frozen embryo transfer | freeze-all embryo was performed after oocyte fertilization, the hormone including FSH, LH, E2 and progesterone was test before oocyte pick up and embryo transfer for analysis.
vitrification of pronuclear stage embryo (zygote) and frozen embryo transfer Receives: Diagnostic Test: progesterone; Diagnostic Test: day 3 embryo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
HCG test
Measured: HCG test at day 15 after embryo transfer or day 18 after oocyte pick up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 May 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh, Chung Shan Medical University
- Investigators
- Maw-Shang Lee, Phd, Study chair, Lee Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317548
- Sponsor's protocol ID
- CS17064
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung Shan Medical University Hospital
- ClinicalTrials.gov ID
- NCT03317548
- Acronym / sponsor ID
- CS17064
- Conditions
- Infertility, Female, Reproductive Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 23 Oct 2017 (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.
The aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (IVF). All frozen embryo was vitrified at pronuclear stage (2PN) and cultured to cleavage embryos for transfer.
This is a retrospective study. All IVF cycles were included in this study and further divided into fresh and frozen embryo transfer groups. The collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. The primary outcome is pregnancy rate and secondary outcome is implantation rate.
Detailed description
Study design
Study progress:
Stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups.
Stage 2: selection data and check the delivery outcomes Stage 3: analysis data and presentation. Including criteria: all patients who underwent IVF. Excluding criteria: No. Statistics analysis: chi-test, t-test
Assessment point:
Primary endpoint: pregnancy rate Secondary endpoint: implantation rate Withdraw criteria: not application. Treatments: not application. Collection number: 500 patients. Scheduled trial period: 2017.05.01~2018.04.30
Expected research results:
The implantation rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.
The pregnancy rate in frozen embryo transfer group which vitrified at 2PN stage is higher than fresh embryo transfer.
This study is only data analysis, no additional collection of samples. This study does not involve vulnerable groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fresh embryo transfer | – | Diagnostic Test: progesterone, Diagnostic Test: day 3 embryopatients with fresh day 3 embryo transfer after oocyte pick up, the hormone including FSH, LH, E2 and progesterone was test before embryo transfer for analysis. The clinical outcomes including implantation and pregnancy were checked and recorded. |
| frozen embryo transfer | – | Diagnostic Test: progesterone, Diagnostic Test: day 3 embryofreeze-all embryo was performed after oocyte fertilization, the hormone including FSH, LH, E2 and progesterone was test before oocyte pick up and embryo transfer for analysis. vitrification of pronuclear stage embryo (zygote) and frozen embryo transfer |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all patients underwent in vitro fertilization protocols in Lee Women's Hospital
Key inclusion criteria (1 listed)
- all patients with in vitro fertilization protocols
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| progesteroneaccording progesterone level to decide fresh or frozen embryo transfer | Diagnostic test | fresh embryo transfer, frozen embryo transfer |
| day 3 embryoaccording day 3 embryo to decide fresh or frozen embryo transfer | Diagnostic test | fresh embryo transfer, frozen embryo transfer |
Primary outcome
pregnancy rate
Time frame: HCG test at day 15 after embryo transfer or day 18 after oocyte pick up
HCG test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Individual participant dataSharing planned: Undecided
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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.
Maw-Shang Lee, Phd study chair
Lee Women's Hospital
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 and Reproductive Disorder, run by Chung Shan Medical University at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Oct 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maw-Shang Lee, Phd (22347057 ext. 1234, msleephd@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: HCG test at day 15 after embryo transfer or day 18 after oocyte pick up). 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 Oct 2017.