Infertility Assisted Reproductive TechnologyPORNCT06950476
ART Cycle Outcomes When Only 1 to 3 Oocytes Are Retrieved
An observational study of Infertility Assisted Reproductive Technology and Oocyte Retrieval, run by Istituto Clinico Humanitas.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility Assisted Reproductive Technology, Oocyte Retrieval
- What is being tested?
- Oocyte Retrieval
- Type of treatment
- Surgery or procedure
- How many people
- 3,761 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- The study database will exclude women who underwent IVF treatment and retrieved more than 3 oocytes following controlled ovarian stimulation.
About this study
Official 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
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:
Read more
- 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.
- Being tested
- Oocyte Retrieval
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte RetrievalProcedure or surgery
Oocyte retrieval is performed at the end of ovarian stimulation (OS) to collect oocytes for use in IVF or ICSI cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: January 2010 - December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jan 2010
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 3,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950476
- Sponsor's protocol ID
- POOR RESPONDERS
- Acronym
- POR
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06950476
- Acronym / sponsor ID
- POR / POOR RESPONDERS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,761 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- The study database will exclude women who underwent IVF treatment and retrieved more than 3 oocytes following controlled ovarian stimulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oocyte RetrievalOocyte retrieval is performed at the end of ovarian stimulation (OS) to collect oocytes for use in IVF or ICSI cycles. | Procedure or surgery | – |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Assisted Reproductive Technology and Oocyte Retrieval, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (CPR) (time frame: January 2010 - December 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.