ART Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved (POR)

May 4, 2025 updated by: Istituto Clinico Humanitas

Assisted Reproductive Technology Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved: a Retrospective Analysis of 3,671 Cycles in Poor Responders From a Large Volume Single Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3761

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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
Clinical Pregnancy Rate (CPR)
Time Frame: January 2010 - December 2023

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)
Time Frame: January 2010 - December 2023
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
Time Frame: January 2010 - December 2023

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

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, 2010

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 28, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POOR RESPONDERS

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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