in Vitro FertilisationNCT06260787
Clinical Profiles And In Vitro Fertilization Success
An observational study of in Vitro Fertilisation, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- in Vitro Fertilisation
- What is being tested?
- In Vitro Fertilisation
- Type of treatment
- Surgery or procedure
- How many people
- 223 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 31 Dec 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: In vitro fertilisation patients undergoing treatment at our facility
Who may be able to join
- medical record data for in vitro fertilization patients at our facility from January 1,2017 to December 31, 2021
Who cannot join
- incomplete patient medical record data.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran
Bandung, West Java, 40161
About this study
Official title: The Relationship Between Clinical Profiles And The Success Rate Of In Vitro Fertilization Patients - Experience From Indonesia
This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021.
Read the detailed description
This study was conducted to determine whether there is an association between the clinical profile of in vitro fertilization patients and the success of pregnancy after in vitro fertilization in infertility patients.
The research was a cross sectional study using total sampling method, conducted on 223 infertility patients who performed in vitro fertilization at a tertiary fertility center in Bandung, Indonesia within the period January 2017-December 2021. Secondary data using medical records was taken.
We aimed to identify associations between the patient's age, the male partner's age, infertility duration, IVF protocol, fresh/frozen embryo, various infertility etiologies and the pregnancy rate in IVF programs. A p-value <0.05 is considered significant.
- Conditions
- in Vitro Fertilisation
- Being tested
- In Vitro Fertilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vitro FertilisationProcedure or surgery
Assisted reproductive technology in the form of in vitro fertilisation
| Study group | Role | What they receive |
|---|---|---|
| In Vitro Fertilisation | Patients undergoing in vitro fertilisation at our tertiary fertility center facility Receives: Procedure: In Vitro Fertilisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Total number of patients getting pregnant divided by the number of total patients enrolled
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Vitro FertilisationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanom H Syam, M.D., Ph.D, Principal investigator, Permanent Staff at the Department of Obstetrics and Gynecology, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260787
- Sponsor's protocol ID
- OBGY-202401.01
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised patient data may be requested to the sponsor/primary researcher if required
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Clinical Profiles And The Success Rate Of In Vitro Fertilization Patients - Experience From Indonesia
- ClinicalTrials.gov ID
- NCT06260787
- Acronym / sponsor ID
- OBGY-202401.01
- Conditions
- in Vitro Fertilisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Feb 2024 (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 research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021.
Detailed description
This study was conducted to determine whether there is an association between the clinical profile of in vitro fertilization patients and the success of pregnancy after in vitro fertilization in infertility patients.
The research was a cross sectional study using total sampling method, conducted on 223 infertility patients who performed in vitro fertilization at a tertiary fertility center in Bandung, Indonesia within the period January 2017-December 2021. Secondary data using medical records was taken.
We aimed to identify associations between the patient's age, the male partner's age, infertility duration, IVF protocol, fresh/frozen embryo, various infertility etiologies and the pregnancy rate in IVF programs. A p-value <0.05 is considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Vitro Fertilisation | – | Procedure: In Vitro FertilisationPatients undergoing in vitro fertilisation at our tertiary fertility center facility |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In vitro fertilisation patients undergoing treatment at our facility
Key inclusion criteria (1 listed)
- medical record data for in vitro fertilization patients at our facility from January 1,2017 to December 31, 2021
Key exclusion criteria (1 listed)
- incomplete patient medical record data.
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 |
|---|---|---|
| In Vitro FertilisationAssisted reproductive technology in the form of in vitro fertilisation | Procedure or surgery | In Vitro Fertilisation |
Primary outcome
Pregnancy rate
Time frame: 5 years
Total number of patients getting pregnant divided by the number of total patients enrolled
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 15 Feb 2024.
- Individual participant dataSharing planned: No. Anonymised patient data may be requested to the sponsor/primary researcher if required
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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.
Hanom H Syam, M.D., Ph.D principal investigator
Permanent Staff at the Department of Obstetrics and Gynecology, Universitas Padjadjaran
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 in Vitro Fertilisation, run by Universitas Padjadjaran at 1 site in Indonesia.
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 15 Feb 2024. 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 Indonesia. 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?
Pregnancy rate (time frame: 5 years). 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 15 Feb 2024.