Recurrent Pregnancy LossNCT04621773
Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss
An observational study of Recurrent Pregnancy Loss and Preimplantation Genetic Screening, run by Peking University Third Hospital at 1 site in China.
Trial summary
STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Preimplantation Genetic Screening
- What is being tested?
- Preimplantation Genetic Screening(exposure)
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 1 Sep 2025
- How long will I take part?
- 2 Years
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: patients who seek treatment in our Recurrent Pregnancy Loss clinic.
Who may be able to join
- patients with two times or more unexplained pregnancy loss(less than 24 weeks of gestational age, biochemical pregnancy excluded), who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy.
Who cannot join
- anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.
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: Comparing the Live Birth Rate of Preimplantation Genetic Screening Versus Spontaneous Pregnancy in Patients With Unexplained Recurrent Pregnancy Loss
STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.
Read the detailed description
400 patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy are intended to be enrolled. They are going to divided into two groups: PGS(preimplantation genetic screening) group and SP(spontaneous pregnancy) group. The pregnancy outcomes and offspring development of those patients will be followed up by our investigators.
- Being tested
- Preimplantation Genetic Screening(exposure)
- Keywords
- Unexplained Recurrent Pregnancy Loss, Preimplantation Genetic Screening, spontaneous pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic Screening(exposure)Procedure or surgery
Preimplantation genetic screening (PGS) was developed in the late 1980s as an alternative to prenatal diagnosis for couples at risk of transmitting a genetic or chromosomal abnormality to their children. In embryos created through in vitro fertilisation (IVF), cells are biopsied and analysed using genetic tests such as polymerase chain reaction and fluorescent in situ hybridisation (FISH).
| Study group | Role | What they receive |
|---|---|---|
| PGS(Preimplantation Genetic Screening) | patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure Receives: Procedure: Preimplantation Genetic Screening(exposure) | |
| SP(spontaneous pregnancy ) | patients with two times or more unexplained pregnancy loss, who wants to be pregnant via spontaneous pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
the rate of the birth of a living fetus
Measured: 2 years of following up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2025 (estimated)
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 Recurrent 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rong Li, M.D., Study chair, Center of Reproductive Medicine, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621773
- Sponsor's protocol ID
- 2019SZ-087
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murugappan G, Shahine LK, Perfetto CO, Hickok LR, Lathi RB. Intent to treat analysis of in vitro fertilization and preimplantation genetic screening versus expectant management in patients with recurrent pregnancy loss. Hum Reprod. 2016 Aug;31(8):1668-74. doi: 10.1093/humrep/dew135. Epub 2016 Jun 7.
PubMed 27278003
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Live Birth Rate of Preimplantation Genetic Screening Versus Spontaneous Pregnancy in Patients With Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT04621773
- Acronym / sponsor ID
- 2019SZ-087
- Keywords
- Unexplained Recurrent Pregnancy Loss, Preimplantation Genetic Screening, spontaneous pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 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.
STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.
Detailed description
400 patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy are intended to be enrolled. They are going to divided into two groups: PGS(preimplantation genetic screening) group and SP(spontaneous pregnancy) group. The pregnancy outcomes and offspring development of those patients will be followed up by our investigators.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGS(Preimplantation Genetic Screening) | – | Procedure: Preimplantation Genetic Screening(exposure)patients with two times or more unexplained pregnancy loss, who wants to be pregnant via preimplantation genetic screening procedure |
| SP(spontaneous pregnancy ) | – | –patients with two times or more unexplained pregnancy loss, who wants to be pregnant via spontaneous pregnancy. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients who seek treatment in our Recurrent Pregnancy Loss clinic.
Key inclusion criteria (1 listed)
- patients with two times or more unexplained pregnancy loss(less than 24 weeks of gestational age, biochemical pregnancy excluded), who wants to be pregnant via preimplantation genetic screening procedure or spontaneous pregnancy.
Key exclusion criteria (1 listed)
- anatomic abnormality of the reproductive system; endocrine metabolic disease; autoimmune related disease; chromosomal abnormalities; hydrosalpinx; cervical insufficiency.
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 |
|---|---|---|
| Preimplantation Genetic Screening(exposure)Preimplantation genetic screening (PGS) was developed in the late 1980s as an alternative to prenatal diagnosis for couples at risk of transmitting a genetic or chromosomal abnormality to their children. In embryos created through in vitro fertilisation (IVF), cells are biopsied and analysed using genetic tests such as polymerase chain reaction and fluorescent in situ hybridisation (FISH). | Procedure or surgery | PGS(Preimplantation Genetic Screening) |
Primary outcome
Live birth rate
Time frame: 2 years of following up
the rate of the birth of a living fetus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
- Background: PubMed 27278003Murugappan G, Shahine LK, Perfetto CO, Hickok LR, Lathi RB. Intent to treat analysis of in vitro fertilization and preimplantation genetic screening versus expectant management in patients with recurrent pregnancy loss. Hum Reprod. 2016 Aug;31(8):1668-74. doi: 10.1093/humrep/dew135. Epub 2016 Jun 7.
- 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.
Rong Li, M.D. study chair
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 Pregnancy Loss and Preimplantation Genetic Screening, 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: status not confirmed, as of the sponsor's last update on 9 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?
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: 2 years of following up). 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 NCT04621773, 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 9 Nov 2020.