ART Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved

NCT06950476 | Completed

• 1 other identifier: POOR RESPONDERS
• Study Type: observational
• Target: 3,761
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a monocentric retrospective observational study. The study focuses on the women who underwent Assisted Reproductive Technology (ART) cycles with poor ovarian response (POR), defined as \<4 oocytes retrieved. The objectives of the study are as follows:

• Evaluate clinical pregnancy rate (CPR) and cumulative live birth rate (CLBR) in women with poor ovarian response.
• Evaluate abortion rate in women with poor ovarian response.
• Evaluate the influence of patient characteristics (age, Anti-Müllerian hormone \[AMH\] levels, Antral Follicle Count \[AFC\], Follicle Stimulating Hormone \[FSH\], Body Mass Index \[BMI\]) on women with poor ovarian response. 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 2010 to December 2023 will be included in the evaluation. Outcomes will be expressed in terms of CLBR, CPR and Abortion Rate.

Conditions

Infertility Assisted Reproductive Technology; Oocyte Retrieval

Outcome Measures

Primary Outcomes (3)

• Clinical Pregnancy Rate (CPR)

  This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on clinical pregnancy rate. The CPR is defined as the number of clinical pregnancies expressed per 100 initiated cycles.

  January 2010 - December 2023

• Cumulative Live Birth Rate (CLBR)

  This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on cumulative live birth rates The CLBR is defined as the likelihood of achieving at least one live birth over a series of treatment cycles, including both fresh and frozen embryo transfers, originating from a single ovarian stimulation.

  January 2010 - December 2023

• Abortion Rate

  This study aims to evaluate the ART outcomes in women classified as poor ovarian responders (POR), focusing on abortion rates. Abortion rate is defined as the presence of an empty gestational sac or a gestational sac containing an embryo or fetus without fetal cardiac activity, occurring within the first 12 6/7 weeks of gestation.

  January 2010 - December 2023

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 patients registered in the Humanitas Fertility Center database between January 2010 and December 2023, matching the inclusion and exclusion criteria cited above.

You may qualify if:

• The study database will include all women who underwent IVF treatment between 2010 and 2023 and were classified as poor ovarian responders, defined as those who retrieved fewer than 4 oocytes following controlled ovarian stimulation.

You may not qualify if:

• The study database will exclude women who underwent IVF treatment and retrieved more than 3 oocytes following controlled ovarian stimulation.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

MeSH Terms

Interventions

Oocyte Retrieval

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: April 28, 2025
• First Posted: April 30, 2025
• Study Start: January 1, 2010
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 7, 2025

Record last verified: 2025-05