Infertility, FemaleNCT05232019
Association Between Embryo Implantation Rate and Maternal Age
An observational study of Infertility, Female, run by Nanjing University at 1 site in China.
Trial summary
To explore the relationship between maternal age and embryo implantation rate in patients undergoing assisted reproductive technology. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Infertility, Female
- How many people
- 17,394 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 Dec 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile females no less than 20 years old who were attending our clinical center for the first time were enlisted. In total, 17394 patients suffering from primary or secondary infertility were enrolled in this study.
Who may be able to join
- infertile patients
- attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time
- had experienced no less than one embryo transplantation between January 2015 and December 2019
Who cannot join
- canceled embryo transplantation cycles for any reason
Trial locations and contacts
1 site in 1 country.
China1 site
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: Association Between Embryo Implantation Rate and Maternal Age in Different Embryo Transplantation Cycles: a Retrospective Cohort Study
To explore the relationship between maternal age and embryo implantation rate in patients undergoing assisted reproductive technology.
Read the detailed description
The investigators designed a retrospective clinical trial conducted from January 2015 to December 2020 at the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School. Infertility was defined as the failure of a clinical pregnancy after 12 months or more of regular unprotected intercourse with the same marriage partner. Patients experiencing infertility no younger than the age of 20 who attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time and had experienced no less than one embryo transplantation between January 2015 and December 2019 were recruited. Patients who had experienced or canceled embryo transplantation cycles for any reason were excluded from this study. The gap year from December 2019 to December 2020 allowed researchers to follow up on the outcomes of pregnancies before 2020. Frozen cycles were performed when high-quality embryos existed to avoid unnecessary ovarian stimulation and oocyte retrieval processes. Investigators were blinded to the outcome of embryo transplantation, and information on pregnancy was gathered through telephone follow-up one year after transplantation.
- Conditions
- Infertility, Female
- Medical subject headings
- Infertility, Female
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 |
|---|---|---|
| Infertile females | No less than 20 years old who were attending our clinical center for the first time were enlisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo implantation rate
Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo
Measured: 60 days after embryo transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Jan 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
- Investigators
- Haixiang Sun, PhD, Study director, The affiliated Drum Towel Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232019
- Sponsor's protocol ID
- SZ-2021-RIF
- Status last verified
- Feb 2022
- First submitted
- 29 Jan 2022
- Last updated
- 22 Feb 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 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Embryo Implantation Rate and Maternal Age in Different Embryo Transplantation Cycles: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05232019
- Acronym / sponsor ID
- SZ-2021-RIF
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,394 participants (actual)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 Feb 2022 (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.
To explore the relationship between maternal age and embryo implantation rate in patients undergoing assisted reproductive technology.
Detailed description
The investigators designed a retrospective clinical trial conducted from January 2015 to December 2020 at the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School. Infertility was defined as the failure of a clinical pregnancy after 12 months or more of regular unprotected intercourse with the same marriage partner. Patients experiencing infertility no younger than the age of 20 who attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time and had experienced no less than one embryo transplantation between January 2015 and December 2019 were recruited. Patients who had experienced or canceled embryo transplantation cycles for any reason were excluded from this study. The gap year from December 2019 to December 2020 allowed researchers to follow up on the outcomes of pregnancies before 2020. Frozen cycles were performed when high-quality embryos existed to avoid unnecessary ovarian stimulation and oocyte retrieval processes. Investigators were blinded to the outcome of embryo transplantation, and information on pregnancy was gathered through telephone follow-up one year after transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile females | – | –No less than 20 years old who were attending our clinical center for the first time were enlisted |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile females no less than 20 years old who were attending our clinical center for the first time were enlisted. In total, 17394 patients suffering from primary or secondary infertility were enrolled in this study.
Key inclusion criteria (3 listed)
- infertile patients
- attended the Reproductive Medicine Center of the Affiliated Drum Tower Hospital of Nanjing University Medical School for the first time
- had experienced no less than one embryo transplantation between January 2015 and December 2019
Key exclusion criteria (1 listed)
- canceled embryo transplantation cycles for any reason
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
embryo implantation rate
Time frame: 60 days after embryo transplantation
Fetal heartbeat can be visualized via ultrasound in order to definitely confirm the implantation of the embryo
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 22 Feb 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.
Haixiang Sun, PhD study director
The affiliated Drum Towel Hospital of Nanjing University Medical School
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 Infertility, Female, run by Nanjing University 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 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 22 Feb 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?
embryo implantation rate (time frame: 60 days after embryo transplantation). 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 22 Feb 2022.