Impact of the Operator Performing Oocyte Retrieval on the Cumulative Live Birth Rate

NCT06933901 | Completed

• 1 other identifier: OPERATOR-PICK-UP-CLBR
• Study Type: observational
• Target: 19,500
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Infertility (IVF Patients); Oocyte Retrieval

Outcome Measures

Primary Outcomes (1)

• 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.

  January 2013 - December 2022

Interventions

Oocyte retrieval PROCEDURE

Oocyte retrieval is performed at the end of ovarian stimulation (OS) to collect oocytes for use in IVF or ICSI cycles.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Conditions

Infertility

Interventions

Oocyte Retrieval

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Tissue and Organ Harvesting; Transplantation; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: April 18, 2025
• Study Start: January 1, 2013
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 25, 2025

Record last verified: 2025-04