Infertility, FemaleNCT03312309
Personal FET in RIF Patients According to Histological Dating of Endometrial of Natural/ Hormone Replacement Cycle
A study testing personal embryo transfer in people with Infertility, Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- personal embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2017to 28 Feb 2018
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria for RIF group were:
- •unexplained repeated implantation failure (RIF) which is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers.
- The inclusion criteria for control group were:
- age <35 years;
- regular menstrual cycles of 24-35 days;
- baseline follicle- stimulating hormone (FSH) < 9.0 IU/L;
- endometrial thickness ≥8.0 mm on the day of hCG administration.
Who cannot join
- uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus);
- intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)
- history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410000
About this study
Official title: Personal Frozen-thawed Embryo Transfer in Unexplained RIF Patients According to the Blinded Histological Dating of Endometrial Biopsies of Natural/ Hormone Replacement Cycle
At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown that the window of implantation (WOI) is displaced in only a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance with higher cost .what is known to the others'population? 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''. But such pET studies according to the Noyes criterion are lacking . The aim of this study is to explore the Personal frozen-thawed embryo transfer in unexplained RIF patients according to the blinded histological dating of endometrial biopsies .
- Conditions
- Infertility, Female
- Being tested
- personal 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.
personal embryo transferProcedure or surgery
According to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle .
pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles.
| Study group | Role | What they receive |
|---|---|---|
| RIF group | Experimental | According to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle .
pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles. Receives: Procedure: personal embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
clinical pregnancy rate
Measured: at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer
Secondary outcomes (1)
Biochemical pregnancy
Biochemical pregnancy
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start17 Oct 2017
- Primary completion31 Dec 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-Xiangya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yuan li, doctor, Study chair, Reproductive & Genetic Hospital of CITIC-Xiangya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312309
- Sponsor's protocol ID
- KYXM-201702-02
- Status last verified
- Jan 2022
- First submitted
- 12 Oct 2017
- Last updated
- 11 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Li XF, Liao JN, Fan XX, Hu YB, Gan R, Lu G, Lin G, Gong F. Clinical value of histologic endometrial dating for personalized frozen-thawed embryo transfer in patients with repeated implantation failure in natural cycles. BMC Pregnancy Childbirth. 2020 Sep 11;20(1):527. doi: 10.1186/s12884-020-03217-y.
PubMed 32917168
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Frozen-thawed Embryo Transfer in Unexplained RIF Patients According to the Blinded Histological Dating of Endometrial Biopsies of Natural/ Hormone Replacement Cycle
- ClinicalTrials.gov ID
- NCT03312309
- Acronym / sponsor ID
- KYXM-201702-02
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 17 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.
At present, the evaluation criterion of endometrial receptivity is controversial. The development of a molecular diagnostic tool, the endometrial receptivity array (ERA) for diagnosis of endometrial receptivity . But use of this test in patients with RIF has shown that the window of implantation (WOI) is displaced in only a quarter of these patients and use of a personalized embryo transfer (pET) on the day designated by ERA improves reproductive performance with higher cost .what is known to the others'population? 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''. But such pET studies according to the Noyes criterion are lacking . The aim of this study is to explore the Personal frozen-thawed embryo transfer in unexplained RIF patients according to the blinded histological dating of endometrial biopsies .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIF group | Experimental | Procedure: personal embryo transferAccording to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer . The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle . pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- •unexplained repeated implantation failure (RIF) which is defined as the absence of a gestational sac on ultrasound at 5 or more weeks after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after the transfer of ≥10 embryos in multiple transfers.
- age <35 years;
- regular menstrual cycles of 24-35 days;
- baseline follicle- stimulating hormone (FSH) < 9.0 IU/L;
- endometrial thickness ≥8.0 mm on the day of hCG administration.
Key exclusion criteria (3 listed)
- uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus);
- intrauterine adhesions（moderate - severe）, endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure)
- history of adverse pregnancy (including spontaneous abortion, stillbirth, and fetal malformation).
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 |
|---|---|---|
| personal embryo transferAccording to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer . The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle . pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles. | Procedure or surgery | RIF group |
Primary outcome
clinical pregnancy rate
Time frame: at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer
clinical pregnancy rate
1 secondary outcome
Biochemical pregnancy
Time frame: 14 days after embryo transfer
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 11 Jan 2022.
- Derived from this study: PubMed 32917168Li Y, Li XF, Liao JN, Fan XX, Hu YB, Gan R, Lu G, Lin G, Gong F. Clinical value of histologic endometrial dating for personalized frozen-thawed embryo transfer in patients with repeated implantation failure in natural cycles. BMC Pregnancy Childbirth. 2020 Sep 11;20(1):527. doi: 10.1186/s12884-020-03217-y.
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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.
yuan li, doctor study chair
Reproductive & Genetic Hospital of CITIC-Xiangya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personal embryo transfer in people with Infertility, Female, run by Reproductive & Genetic Hospital of CITIC-Xiangya 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 7 inclusion and 3 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 11 Jan 2022. 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?
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?
clinical pregnancy rate (time frame: at least one intrauterine gestational sac with cardiac action by ultrasound performed 28 days after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312309, which also lists 1 linked publication.
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 11 Jan 2022.