Impact of the Operator Performing Oocyte Retrieval on the Cumulative Live Birth Rate (OPU-CLBR)

April 22, 2025 updated by: Istituto Clinico Humanitas

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:

  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

19500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 2013 - December 2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

April 10, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPERATOR-PICK-UP-CLBR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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