InfertilityNCT02868528
A Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women
A study testing chromosome screening with NGS technology in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
With the development of society, more and more aged pregnant women because of various reasons, their abnormality rate of egg chromosome was higher than that of young women, then the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women is lower, abortion rate is higher. Read more about this study
- Who is it for?
- Ages 37 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- chromosome screening with NGS technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2016to Aug 2019
- 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 37 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal females, age ≥37 years ≤44 years
- Have given birth to a healthy baby
- Bilateral ovaries
- Antral follicle count(AFC)≥10,and Anti Mullerian Hormone (AMH)≥2.0 ng/ml
Who cannot join
- Endometriosis disease
- Intrauterine adhesions history; intrauterine membrane polyp, tuberculosis and inflammation,
- Uterine malformation, multiple uterine myoma, uterine intramural myoma >3cm, submucous myoma;
- Unprocessed hydrosalpinx
- Adverse reproductive history; greater than or equal to 2 times history of unexplained abortion
- Chromosomal abnormalities or other genetic disease
Show all 12Show fewer
- Infertility caused by male factors, such as puncture testicular, SRT did not see the class A and class B sperm
- Without high quality embryos in past controlled ovarian hyperstimulation (COH)cycles.
- Patients with poor ovarian response, the standard of poor ovarian response accords with Bolognacriteria standard, that is at least meet 2 among the following 3:
- . Elder years (≥40 years) or have other known inherited or acquired risk factors that may reduce follicle.
- .History of cancellation of the cycles because of less than 3 follicular development, or history of egg number less than 4 after at least using Follicle-Stimulating Hormone(FSH) 150IU once a day.
- .Ovarian reserve function test abnormalities, including sinus follicle number less than 5-7 AFC or AMH less than 0.5 to 1.1 ng/ml
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: A Prospective Randomized Controlled Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women
With the development of society, more and more aged pregnant women because of various reasons, their abnormality rate of egg chromosome was higher than that of young women, then the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy termination after the prenatal diagnosis, reduce their pain of body and mind, the investigators will carry out this study. This is a prospective randomized controlled study of preimplantation genetic screening with Next generation sequencing technology. The embryos with more developmental potential and normal chromosomes should be selected. There is no related studies in Chinese. Most international research are limited to fluorescence in situ hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So there is no evidence of the effects of PGS on advanced age women.
This study is to compare the outcomes between the advanced age women with two methods respectively. After blastocyst culture, blastocysts will be transferred in the control group. In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with Next generation sequencing（NGS） technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred. The investigators expect that, in PGS group live birth rate 、cancellation rate and pregnancy rate are higher than in control group; abortion rate is lower than that of the control group.
- Conditions
- Infertility
- Being tested
- chromosome screening with NGS technology
- Keywords
- advanced age women, blastocyst culture, PGS, live birth rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromosome screening with NGS technologyGenetic
| Study group | Role | What they receive |
|---|---|---|
| PGS group | Experimental | After blastocyst culture, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with NGS technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred. Receives: Genetic: chromosome screening with NGS technology |
| control group | No intervention | After blastocyst culture, blastocysts will be transferred |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
Measured: At birth
Secondary outcomes (3)
cancellation rate
Measured: Up to the day of embryo transferred
Pregnancy Rate
Measured: Up to 28th day after embryo transferred
abortion rate
Measured: Through pregnancy period，average 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study start23 Sep 2016
- Primary completionMay 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- None (open label)
- Enrolment
- 124 participants (actual)
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
- NCT02868528
- Sponsor's protocol ID
- KYXM-201603
- Status last verified
- Mar 2020
- First submitted
- 10 Aug 2016
- Last updated
- 26 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Preimplantation Genetic Screening With Next Generation Sequencing Technology on Advanced Age Women
- ClinicalTrials.gov ID
- NCT02868528
- Acronym / sponsor ID
- KYXM-201603
- Conditions
- Infertility
- Keywords
- advanced age women, blastocyst culture, PGS, live birth rate
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 16 Aug 2016 (estimated)
- 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.
With the development of society, more and more aged pregnant women because of various reasons, their abnormality rate of egg chromosome was higher than that of young women, then the abnormality rate of embryo chromosome is higher too, so the pregnancy rate in aged women is lower, abortion rate is higher. In order to improve the pregnancy rate in aged women, cut down their abortion rate 、fetal birth with abnormal chromosome, and the risk of pregnancy termination after the prenatal diagnosis, reduce their pain of body and mind, the investigators will carry out this study. This is a prospective randomized controlled study of preimplantation genetic screening with Next generation sequencing technology. The embryos with more developmental potential and normal chromosomes should be selected. There is no related studies in Chinese. Most international research are limited to fluorescence in situ hybridization (FISH) technique, not on the embryo chromosome comprehensive screening. So there is no evidence of the effects of PGS on advanced age women.
This study is to compare the outcomes between the advanced age women with two methods respectively. After blastocyst culture, blastocysts will be transferred in the control group. In the Preimplantation Genetic Screening (PGS) group, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with Next generation sequencing（NGS） technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred. The investigators expect that, in PGS group live birth rate 、cancellation rate and pregnancy rate are higher than in control group; abortion rate is lower than that of the control group.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGS group | Experimental | Genetic: chromosome screening with NGS technologyAfter blastocyst culture, blastocyst embryo trophoblast biopsy will be performed and chromosome screening with NGS technology, at the same time, the blastocysts will be frozen, then the blastocysts with normal chromosome will be thawed and transferred. |
| control group | No intervention | –After blastocyst culture, blastocysts will be transferred |
Who may qualify
- Ages
- 37 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Premenopausal females, age ≥37 years ≤44 years
- Have given birth to a healthy baby
- Bilateral ovaries
- Antral follicle count(AFC)≥10,and Anti Mullerian Hormone (AMH)≥2.0 ng/ml
Key exclusion criteria (12 listed)
- Endometriosis disease
- Intrauterine adhesions history; intrauterine membrane polyp, tuberculosis and inflammation,
- Uterine malformation, multiple uterine myoma, uterine intramural myoma >3cm, submucous myoma;
- Unprocessed hydrosalpinx
- Adverse reproductive history; greater than or equal to 2 times history of unexplained abortion
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 |
|---|---|---|
| chromosome screening with NGS technology | Genetic | PGS group |
Primary outcome
live birth rate
Time frame: At birth
3 secondary outcomes
cancellation rate
Time frame: Up to the day of embryo transferred
Pregnancy Rate
Time frame: Up to 28th day after embryo transferred
abortion rate
Time frame: Through pregnancy period，average 10 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chromosome screening with NGS technology in people with Infertility, 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 26 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 was stopped early. 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?
live birth rate (time frame: At birth). 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 26 Jan 2022.