Infertility, FemaleNCT03910582
Personalized FET in RIF Patients With Displaced Dating
A study testing personalized frozen-thawed embryo transfer and routine frozen-thawed embryo transfer in people with Infertility, Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya.
Trial summary
The endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. The exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- personalized frozen-thawed embryo transfer and routine frozen-thawed embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 10 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 20 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- RIF patients (RIF is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers);
- Out of phase dating patients;
- FET in natural cycle;
- Single blastocysts embryo transfer;
Who cannot join
- 1. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine fibroids (submucosal fibroids, non-mucosal fibroids> 4 cm and/or endometrial pressure);
About this study
Official title: A Randomized Clinical Trial of Endometrial Histological Dating for Personalized Frozen-thawed Embryo Transfer (pFET) in Patients With Repeated Implantation Failure (RIF) in Natural Cycle
The endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. The exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950. An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be "out of phase" However, the clinical application of the Noyes criterion is relatively limited. We have verified the Noyes criterion in natural cycle in previous study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data).
The clinical value of the endometrial histological dating in RIF patients in natural cycle is still to be answered. In this study, we tried to investigate the clinical effects of pFET in unexplained RIF patients according to the use of classic histologic endometrial dating to estimate the timing of the window of implantation and to adjust embryo transfer time in natural cycle.
- Conditions
- Infertility, Female
- Being tested
- personalized frozen-thawed embryo transfer, routine frozen-thawed embryo transfer
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized frozen-thawed embryo transferProcedure or surgery
The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group
routine frozen-thawed embryo transferProcedure or surgery
The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects in this group will be treated with personalized frozen-thawed embryo transfer. The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group Receives: Procedure: personalized frozen-thawed embryo transfer |
| Control group | Active comparator | Subjects in this group will be treated with routine frozen-thawed embryo transfer.The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group. Receives: Procedure: routine frozen-thawed embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
ongoing clinical rate
Ongoing pregnancy was defined as at least one intrauterine gestational sac with cardiac action by ultrasound performed 6 weeks after ET.
Measured: 6 weeks
Secondary outcomes (3)
implantation rate
Measured: 2 weeks
clinical pregnancy rate
Measured: 4 weeks
early abortion rate
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start15 Sep 2020 (estimated)
- Primary completion10 Apr 2021 (estimated)
- Study completion10 Jun 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910582
- Sponsor's protocol ID
- P2019003
- Status last verified
- Mar 2020
- First submitted
- 9 Apr 2019
- Last updated
- 27 Mar 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Endometrial Histological Dating for Personalized Frozen-thawed Embryo Transfer (pFET) in Patients With Repeated Implantation Failure (RIF) in Natural Cycle
- ClinicalTrials.gov ID
- NCT03910582
- Acronym / sponsor ID
- P2019003
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 10 Apr 2021 (estimated)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 10 Apr 2019 (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 endometrium becomes receptive as a result of a series of timed hormonal events during the menstrual cycle. The exposure of the endometrium to progesterone after ovulation initiates morphological and functional alterations that result in the change from a pre-receptive to a receptive endometrium. The morphological changes observed on histology for each specific day after ovulation were described by Noyes and his colleagues in 1950. An endometrial biopsy that shows a difference of more than 2 days between the histologic dating and actual day after ovulation is considered to be "out of phase" However, the clinical application of the Noyes criterion is relatively limited. We have verified the Noyes criterion in natural cycle in previous study which conducting endometrial biopsies respectively on day 3, 5, 7, 9 and 11 of post-ovulation (PO+3/5/7/9/11)(unpublished data).
The clinical value of the endometrial histological dating in RIF patients in natural cycle is still to be answered. In this study, we tried to investigate the clinical effects of pFET in unexplained RIF patients according to the use of classic histologic endometrial dating to estimate the timing of the window of implantation and to adjust embryo transfer time in natural cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: personalized frozen-thawed embryo transferSubjects in this group will be treated with personalized frozen-thawed embryo transfer. The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group |
| Control group | Active comparator | Procedure: routine frozen-thawed embryo transferSubjects in this group will be treated with routine frozen-thawed embryo transfer.The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group. |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- RIF patients (RIF is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers);
- Out of phase dating patients;
- FET in natural cycle;
- Single blastocysts embryo transfer;
Key exclusion criteria (1 listed)
- 1. uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), intrauterine adhesions, endometriosis,adenomyosis, hydrosalpinx, and uterine fibroids (submucosal fibroids, non-mucosal fibroids> 4 cm and/or endometrial pressure);
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 |
|---|---|---|
| personalized frozen-thawed embryo transferThe blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group | Procedure or surgery | Experimental group |
| routine frozen-thawed embryo transferThe blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group. | Procedure or surgery | Control group |
Primary outcome
ongoing clinical rate
Time frame: 6 weeks
Ongoing pregnancy was defined as at least one intrauterine gestational sac with cardiac action by ultrasound performed 6 weeks after ET.
3 secondary outcomes
implantation rate
Time frame: 2 weeks
clinical pregnancy rate
Time frame: 4 weeks
early abortion rate
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing personalized frozen-thawed embryo transfer and routine frozen-thawed embryo transfer in people with Infertility, Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya.
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 4 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
ongoing clinical rate (time frame: 6 weeks). 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 27 Mar 2020.