Recurrent Early Pregnancy LossNCT04643938
PGT-A in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage
An observational study of Recurrent Early Pregnancy Loss, run by Peking University Third Hospital at 1 site in China.
Trial summary
uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes. Read more about this study
- Who is it for?
- Ages 20 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Early Pregnancy Loss
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Feb 2020
- 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 46 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016
Who may be able to join
- women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016.Only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A.
Who cannot join
- Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.
Trial locations and contacts
1 site in 1 country.
China1 site
Center of Reproductive Medicine, Peking University Third Hospital
Beijing, Haidian, 100191
About this study
Official title: Preimplantation Genetic Testing for Aneuploidy in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage: a Single-center, Prospective Clinical Analysis Based on aCGH Technology
uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.
Read the detailed description
This prospective observational study enrolled all women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016. If a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. All included stimulation cycles involved intracytoplasmic sperm injection insemination. After successfully fertilized embryos formed blastocysts on Day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. The blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. All normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until January 2020.
Clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. The factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with uRM.
- Conditions
- Recurrent Early Pregnancy Loss
- Medical subject headings
- Abortion, Habitual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Two spontaneous abortions | No intervention | |
| three spontaneous abortions | No intervention | |
| Four or more spontaneous abortions | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline characteristics
Age
Measured: January 2012 to December 2016
Baseline characteristics
basal sex hormone
Measured: January 2012 to December 2016
Baseline characteristics
the number of abortion
Measured: January 2012 to December 2016
laboratory outcomes of patients
Oocyte count
Measured: January 2012 to December 2016
laboratory outcomes of patients
Number of blastocysts
Measured: January 2012 to December 2016
clinical outcoms
normal karyotype blastocyst rate
Measured: January 2012 to January 2020
clinical outcoms
live birth rate
Measured: January 2012 to January 2020
clinical outcoms
Cumulative pregnancy rate
Measured: January 2012 to January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Jan 2020
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Early Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Haiyan, Peking University Third Hospital
- Investigators
- Haiyan Wang, M.D., Principal investigator, Center of Reproductive Medicine, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643938
- Sponsor's protocol ID
- 2019SZ-076
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 25 Nov 2020
- 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 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Testing for Aneuploidy in Screening of Embryos in the Treatment of Unexplained Recurrent Miscarriage: a Single-center, Prospective Clinical Analysis Based on aCGH Technology
- ClinicalTrials.gov ID
- NCT04643938
- Acronym / sponsor ID
- 2019SZ-076
- Conditions
- Recurrent Early Pregnancy Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 25 Nov 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.
uRM patients selected PGT-A from 2012 to 2016 were included in this study. Their clinical outcomes were prospectively observed and analyzed to explore the factor influenced the outcomes.
Detailed description
This prospective observational study enrolled all women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016. If a couple underwent multiple stimulation cycles during the research period, only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A. All included stimulation cycles involved intracytoplasmic sperm injection insemination. After successfully fertilized embryos formed blastocysts on Day 5-7, trophoblasts were biopsied to determine embryonic karyotypes. The blastocysts with normal/balanced test results were cryopreserved, whereas abnormal blastocysts were discarded after notifying the patients. All normal blastocysts from a patient were thawed and transferred singly, and the outcomes of all subsequent frozen-thawed embryo transfer cycles were followed-up until January 2020.
Clinical outcomes included the blastocyst formation rate, the proportion of blastocysts with normal karyotypes, and the clinical pregnancy, live birth, and cumulative live birth rates. The factors that affected these clinical outcomes were analyzed to predict outcomes and guide treatment in women with uRM.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Two spontaneous abortions | – | –No intervention |
| three spontaneous abortions | – | –No intervention |
| Four or more spontaneous abortions | – | –No intervention |
Who may qualify
- Ages
- 20 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016
Key inclusion criteria (1 listed)
- women with uRM who underwent array-comparative genomic hybridization (array-CGH) for PGT-A in the Reproductive Medicine Center of Peking University Third Hospital from 2012 to 2016.Only the first cycle was included. All patients underwent adequate clinical and genetic consultations before undergoing PGT-A, and all voluntarily chose PGT-A after fully understanding its risks and benefits. All patients signed the informed consent document of PGT-A.
Key exclusion criteria (1 listed)
- Couples with parental chromosomal abnormalities were excluded, as were women with anatomical abnormalities of the uterus, autoimmune diseases, and endocrine abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline characteristics
Time frame: January 2012 to December 2016
Age
Baseline characteristics
Time frame: January 2012 to December 2016
basal sex hormone
Baseline characteristics
Time frame: January 2012 to December 2016
the number of abortion
laboratory outcomes of patients
Time frame: January 2012 to December 2016
Oocyte count
laboratory outcomes of patients
Time frame: January 2012 to December 2016
Number of blastocysts
clinical outcoms
Time frame: January 2012 to January 2020
normal karyotype blastocyst rate
clinical outcoms
Time frame: January 2012 to January 2020
live birth rate
clinical outcoms
Time frame: January 2012 to January 2020
Cumulative pregnancy rate
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 25 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Haiyan Wang, M.D. principal investigator
Center of Reproductive Medicine, Peking University Third 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 Recurrent Early Pregnancy Loss, run by Peking University Third 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 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: finished, as of the sponsor's last update on 25 Nov 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?
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?
Baseline characteristics (time frame: January 2012 to December 2016). The study lists 8 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 25 Nov 2020.