Infertility (IVF Patients)OPU-CLBRNCT06933901
Impact of the Operator Performing Oocyte Retrieval on the Cumulative Live Birth Rate
An observational study of Infertility (IVF Patients) and Oocyte Retrieval, run by Istituto Clinico Humanitas.
Trial summary
This is a monocentric retrospective observational study. The study investigates the impact of the operator performing the oocyte retrieval on the cumulative live birth rate (CLBR). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility (IVF Patients), Oocyte Retrieval
- What is being tested?
- Oocyte retrieval
- Type of treatment
- Surgery or procedure
- How many people
- 19,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 31 Dec 2022
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study sample will include all operators who performed oocyte retrievals for ART cycles at the Humanitas Fertility Center between January 2013 and December 2022, in accordance with the inclusion and exclusion criteria outlined above.
Who may be able to join
- The study database will include patients who underwent oocyte retrieval procedures with the intention of achieving pregnancy at the Humanitas Fertility Center between January 2013 and December 2022, including repeated ART cycles.
- Operator experience will be assessed based on the number of previously performed oocyte retrieval procedures. All operators who performed at least 50 procedures, either at IRCCS - Humanitas Research Hospital or at another institution, will be included in the study.
Who cannot join
- Patients who underwent preimplantation genetic testing (PGT) cycles, as well as those who underwent cryopreservation for oncological or elective purposes, will be excluded from the study.
- Operators who performed fewer than 50 oocyte retrievals, either at IRCCS - Humanitas Research Hospital or at another institution, will be excluded. Additionally, the first 50 procedures performed by each operator will not be included in the dataset.
About this study
Official title: Does the Operator Performing the Oocyte Retrieval Have an Impact on the Cumulative Live Birth Rate: A Monocentric Retrospective Study
This is a monocentric retrospective observational study. The study investigates the impact of the operator performing the oocyte retrieval on the cumulative live birth rate (CLBR).
The objectives of the study are as follows:
Read more
- To evaluate whether the operator performing the oocyte retrieval influences the probability of pregnancy, expressed as the cumulative live birth rate (CLBR).
- To assess whether operator performance improves with increased experience.
To address the study objectives, data will be collected using a specific internal web-based database. All oocyte retrieval procedures performed at the Humanitas Fertility Center from January 2013 to December 2022 will be included in the evaluation. Outcomes will be expressed in terms of CLBR.
- Conditions
- Infertility (IVF Patients), Oocyte Retrieval
- Being tested
- Oocyte retrieval
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrievalProcedure or surgery
Oocyte retrieval is performed at the end of ovarian stimulation (OS) to collect oocytes for use in IVF or ICSI cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
The primary outcome of this study is the evaluation of whether the operator performing the oocyte retrieval influences the probability of pregnancy, expressed in terms of cumulative live birth rate (CLBR). The CLBR is defined as the proportion of cycles resulting in at least one live birth. This metric is calculated per initiated cycle or per oocyte aspiration and includes all fresh and/or frozen embryo transfers until either a live birth occurs or all embryos have been utilised, whichever occurs first.
Measured: January 2013 - December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jan 2013
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility (IVF Patients)Studies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933901
- Sponsor's protocol ID
- OPERATOR-PICK-UP-CLBR
- Acronym
- OPU-CLBR
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Operator Performing the Oocyte Retrieval Have an Impact on the Cumulative Live Birth Rate: A Monocentric Retrospective Study
- ClinicalTrials.gov ID
- NCT06933901
- Acronym / sponsor ID
- OPU-CLBR / OPERATOR-PICK-UP-CLBR
- Conditions
- Infertility (IVF Patients), Oocyte Retrieval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,500 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Apr 2025 (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 is a monocentric retrospective observational study. The study investigates the impact of the operator performing the oocyte retrieval on the cumulative live birth rate (CLBR).
The objectives of the study are as follows:
- To evaluate whether the operator performing the oocyte retrieval influences the probability of pregnancy, expressed as the cumulative live birth rate (CLBR).
- To assess whether operator performance improves with increased experience.
To address the study objectives, data will be collected using a specific internal web-based database. All oocyte retrieval procedures performed at the Humanitas Fertility Center from January 2013 to December 2022 will be included in the evaluation. Outcomes will be expressed in terms of CLBR.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study sample will include all operators who performed oocyte retrievals for ART cycles at the Humanitas Fertility Center between January 2013 and December 2022, in accordance with the inclusion and exclusion criteria outlined above.
Key inclusion criteria (2 listed)
- The study database will include patients who underwent oocyte retrieval procedures with the intention of achieving pregnancy at the Humanitas Fertility Center between January 2013 and December 2022, including repeated ART cycles.
- Operator experience will be assessed based on the number of previously performed oocyte retrieval procedures. All operators who performed at least 50 procedures, either at IRCCS - Humanitas Research Hospital or at another institution, will be included in the study.
Key exclusion criteria (2 listed)
- Patients who underwent preimplantation genetic testing (PGT) cycles, as well as those who underwent cryopreservation for oncological or elective purposes, will be excluded from the study.
- Operators who performed fewer than 50 oocyte retrievals, either at IRCCS - Humanitas Research Hospital or at another institution, will be excluded. Additionally, the first 50 procedures performed by each operator will not be included in the dataset.
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 |
|---|---|---|
| Oocyte retrievalOocyte retrieval is performed at the end of ovarian stimulation (OS) to collect oocytes for use in IVF or ICSI cycles. | Procedure or surgery | – |
Primary outcome
Cumulative live birth rate
Time frame: January 2013 - December 2022
The primary outcome of this study is the evaluation of whether the operator performing the oocyte retrieval influences the probability of pregnancy, expressed in terms of cumulative live birth rate (CLBR). The CLBR is defined as the proportion of cycles resulting in at least one live birth. This metric is calculated per initiated cycle or per oocyte aspiration and includes all fresh and/or frozen embryo transfers until either a live birth occurs or all embryos have been utilised, whichever occurs first.
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 25 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility (IVF Patients) and Oocyte Retrieval, run by Istituto Clinico Humanitas.
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 2 inclusion and 2 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 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Cumulative live birth rate (time frame: January 2013 - December 2022). 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 25 Apr 2025.