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OpenTrials
Completed

NCT Number: NCT06950476

ART Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oocyte retrieval

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: POR

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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