SubfertilityNCT04538560
Preimplantation Genetic Testing for Aneuploidy of Polar Bodies
A study testing polar body biopsy in people with Subfertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.
Trial summary
This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Read more about this study
- Who is it for?
- Ages 36 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subfertility
- What is being tested?
- polar body biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2020to 30 Apr 2022
- 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 36 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients between their 36th and 42st birthdays;
- absence of any type of genetic abnormality in the patient's personal and family history;
- MⅡ oocytes: 2-9 .
Who cannot join
- treatment involving donor oocytes;
- any type of genetic abnormality or family history of genetic abnormality in subject or partner;
- with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;
- poor embryo quality in previous cycles;
- Preimplantation genetic testing for aneuploidy(PGT-A) cycles;
- MⅡ oocytes ≥10 or ≤ 1;
- three or more previous failed IVF or Intracytoplasmic sperm injection(ICSI) cycles.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive and Genetic Hospital of Citic-xiangya
Changsha, Hunan, 410000
xiaojuan Wang, Doc, +86-731-82355100, 646829625@qq.com
Ge Lin, PhD
About this study
Official title: Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)
This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.
- Conditions
- Subfertility
- Being tested
- polar body biopsy
- Keywords
- poor ovarian respond，, advanced age, Preimplantation Genetic Testing
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polar body biopsyProcedure or surgery
Undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores.
| Study group | Role | What they receive |
|---|---|---|
| Polar body biopsy group | Experimental | The study group will undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. Receives: Procedure: polar body biopsy |
| Control group | No intervention | The control group will undergo routine culture and the transfer priority is determined according to the morphological score only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Measured: 22 months
Secondary outcomes (2)
abortion rate
Measured: 22 months
time required to obtained a live birth
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start20 Oct 2020
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- 20 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
- NCT04538560
- Sponsor's protocol ID
- P2020002
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2020
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preimplantation Genetic Testing for Aneuploidy by Next-generation Sequencing of Polar Bodies in Advanced Maternal Age With Poor Ovarian Responders: a Randomized Clinical Trial (Preliminary Experiments)
- ClinicalTrials.gov ID
- NCT04538560
- Acronym / sponsor ID
- P2020002
- Conditions
- Subfertility
- Keywords
- poor ovarian respond，, advanced age, Preimplantation Genetic Testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Reproductive & Genetic Hospital of CITIC-XiangyaUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 4 Sep 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.
This study intends to randomly group the patients with advanced maternal age and poor ovarian response, and the study group will undergo polar body biopsy, and the next-generation sequencing(NGS) technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. In the control group undergo routine culture and the transfer priority is determined according to the morphological score only. The transfer of frozen embryos at the cleavage or blastocyst stage was permitted. Cumulative live birth rate, miscarriage rate and time required to obtain a live birth up to two ovulatory cycles in a year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polar body biopsy group | Experimental | Procedure: polar body biopsyThe study group will undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. |
| Control group | No intervention | –The control group will undergo routine culture and the transfer priority is determined according to the morphological score only. |
Who may qualify
- Ages
- 36 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients between their 36th and 42st birthdays;
- absence of any type of genetic abnormality in the patient's personal and family history;
- MⅡ oocytes: 2-9 .
Key exclusion criteria (7 listed)
- treatment involving donor oocytes;
- any type of genetic abnormality or family history of genetic abnormality in subject or partner;
- with assisted reproductive technology and pregnancy contraindications and with diseases that have a definite effect on pregnancy;
- poor embryo quality in previous cycles;
- Preimplantation genetic testing for aneuploidy(PGT-A) cycles;
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 |
|---|---|---|
| polar body biopsyUndergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores. | Procedure or surgery | Polar body biopsy group |
Primary outcome
Cumulative live birth rate
Time frame: 22 months
2 secondary outcomes
abortion rate
Time frame: 22 months
time required to obtained a live birth
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polar body biopsy in people with Subfertility, 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 3 inclusion and 7 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 22 months). 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 11 Jan 2022.