In Vitro FertilizationNCT04455191
Comparison of Thawing Embryos in Advance and on the Day of Transfer on Pregnancy Outcomes in FET Cycle
A study testing Thawing Embryos in Advance and Thawing Embryos on the Day of Transfer in people with In Vitro Fertilization and Frozen Embryo Transfer, run by Jinan Central Hospital at 1 site in China.
Trial summary
Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there… Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In Vitro Fertilization, Frozen Embryo Transfer
- What is being tested?
- Thawing Embryos in Advance and Thawing Embryos on the Day of Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2021
- Phase
- Interventional
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged <=35 years old;
- Regular menstrual cycle;
- Baseline follicle stimulating hormone (FSH) <12 IU/L;
- Infertility, pure fallopian tube or/and male factor;
- At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for ET.
Who cannot join
- Patients with repeated transplant failure:
- Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman syndrome;
- Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);
- The endometrial thickness of FET day is <7 mm.
Trial locations and contacts
1 site in 1 country.
China1 site
Jinan Central Hospital Affiliated to Shandong University
Jinan, Shandong, 250013
About this study
Official title: Comparison of the Effects of Thawing Embryos in Advance and Thawing on the Day of Transfer on Pregnancy Outcomes in the Frozen Embryo Transfer Cycle
Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two ways or two types of patients?
Read the detailed description
Although in clinical practice, thawed embryos with appropriate development time will be selected strictly according to the number of days after ovulation, there are still two problems in actual clinical treatment: one is the embryonic factor, although the rate of embryonic development is generally the same, However, the phenomenon of delayed embryo division and development often occurs. The second is the endometrial factor. There are reports that a small number of people will move the transplant window forward, or the transplant window is narrow. This potentially creates the risk of embryo-endometrial mismatch. Based on this, the research team focused on patients with frozen embryo transfer cycles and put forward the strategy of "thawing embryos in advance and prolonging the development period of embryos properly" in an effort to achieve better repair of damage caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore, it is necessary to compare thawing embryos in advance and thawing on the day of transfer on pregnancy outcomes in patients with repeated transplant failure and routine patients respectively.
The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two ways or two types of patients?
- Conditions
- In Vitro Fertilization, Frozen Embryo Transfer
- Being tested
- Thawing Embryos in Advance, Thawing Embryos on the Day of Transfer
- Keywords
- Frozen embryos, Thawing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thawing Embryos in AdvanceProcedure or surgery
Thaw Embryos one day in Advance
Thawing Embryos on the Day of TransferProcedure or surgery
Thaw Embryos on the morning of transfer day.
| Study group | Role | What they receive |
|---|---|---|
| Thawing Embryos in Advance | Experimental | Thawing embryos one day in advance (16:00), 18h before embryos transfer (10:00). Receives: Procedure: Thawing Embryos in Advance |
| Thawing Embryos on the Day of Transfer | Experimental | Thawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00). Receives: Procedure: Thawing Embryos on the Day of Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate (Pregnancy or Not)
Observe the clinical pregnancy rate under different embryo thawing time
Measured: 6 weeks
Live Birth Rate (Birth or Not)
Observe the live birth rate under different embryo thawing time
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jan 2020
- Primary completion31 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinan Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Wu, Jinan Central Hospital
- Investigators
- Yingchun Zhang, Dr, Study director, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455191
- Sponsor's protocol ID
- JianCH-RM2020-001
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Thawing Embryos in Advance and Thawing on the Day of Transfer on Pregnancy Outcomes in the Frozen Embryo Transfer Cycle
- ClinicalTrials.gov ID
- NCT04455191
- Acronym / sponsor ID
- JianCH-RM2020-001
- Conditions
- In Vitro Fertilization, Frozen Embryo Transfer
- Keywords
- Frozen embryos, Thawing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jinan Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Jul 2020 (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.
Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two ways or two types of patients?
Detailed description
Although in clinical practice, thawed embryos with appropriate development time will be selected strictly according to the number of days after ovulation, there are still two problems in actual clinical treatment: one is the embryonic factor, although the rate of embryonic development is generally the same, However, the phenomenon of delayed embryo division and development often occurs. The second is the endometrial factor. There are reports that a small number of people will move the transplant window forward, or the transplant window is narrow. This potentially creates the risk of embryo-endometrial mismatch. Based on this, the research team focused on patients with frozen embryo transfer cycles and put forward the strategy of "thawing embryos in advance and prolonging the development period of embryos properly" in an effort to achieve better repair of damage caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore, it is necessary to compare thawing embryos in advance and thawing on the day of transfer on pregnancy outcomes in patients with repeated transplant failure and routine patients respectively.
The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two ways or two types of patients?
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thawing Embryos in Advance | Experimental | Procedure: Thawing Embryos in AdvanceThawing embryos one day in advance (16:00), 18h before embryos transfer (10:00). |
| Thawing Embryos on the Day of Transfer | Experimental | Procedure: Thawing Embryos on the Day of TransferThawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00). |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged <=35 years old;
- Regular menstrual cycle;
- Baseline follicle stimulating hormone (FSH) <12 IU/L;
- Infertility, pure fallopian tube or/and male factor;
- At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for ET.
Key exclusion criteria (4 listed)
- Patients with repeated transplant failure:
- Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman syndrome;
- Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);
- The endometrial thickness of FET day is <7 mm.
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 |
|---|---|---|
| Thawing Embryos in AdvanceThaw Embryos one day in Advance | Procedure or surgery | Thawing Embryos in Advance |
| Thawing Embryos on the Day of TransferThaw Embryos on the morning of transfer day. | Procedure or surgery | Thawing Embryos on the Day of Transfer |
Primary outcome
Clinical Pregnancy Rate (Pregnancy or Not)
Time frame: 6 weeks
Observe the clinical pregnancy rate under different embryo thawing time
Live Birth Rate (Birth or Not)
Time frame: 40 weeks
Observe the live birth rate under different embryo thawing time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Yingchun Zhang, Dr study director
Jinan Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thawing Embryos in Advance and Thawing Embryos on the Day of Transfer in people with In Vitro Fertilization and Frozen Embryo Transfer, run by Jinan Central Hospital at 1 site in China.
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 5 inclusion and 4 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 7 Jul 2020. 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 China. 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?
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?
Clinical Pregnancy Rate (Pregnancy or Not) (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 7 Jul 2020.