ARTNCT05895227
Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.
An observational study of ART and Infertility, run by Istituto Clinico Humanitas.
Trial summary
The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- ART, Infertility
- What is being tested?
- Oocyte retrieval
- Type of treatment
- Surgery or procedure
- How many people
- 13,193 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 21 Dec 2022
- 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 18 to 45 years
- Women only
- Adult
Study population: Patients that underwent oocyte retrieval procedure at Humanitas Fertility Center during the period January 2017 - December 2022, in IVF/ICSI cycles and fertility preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.
Who may be able to join
- patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation
Who cannot join
- -
About this study
The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed.
Read the detailed description
The main aim is to update our knowledge on oocyte retrieval complication, focusing specifically on hemorrhagic / hemoperitoneum rate.
All retrievals will be retrieved in IVF/ICSI cycles and Fertility Preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.
Data collection goes from January 2017 to December 2022.
- Conditions
- ART, Infertility
- Being tested
- Oocyte retrieval
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrievalProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoperitoneum after oocyte transvaginal retrieval
number of patients with onset of hemoperitoneum
Measured: Oocyte retrievals in the period January 2017- December 2022
Secondary outcomes (6)
Operator of the procedure
assessment of operator experience
Measured: 6 years
Hemoglobin level before and after procedure
evaluation of hemoglobin level before and the day after procedure
Measured: 6 years
Time of symptoms onset
evaluation of first symptoms onset
Measured: 6 years
Loss of blood during procedure
average blood loss
Measured: 6 years
Incidence compared to past case history
comparison with previous statistic
Measured: 6 years
Need for hospitalization
patients requiring hospitalisation
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jan 2017
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARTStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paolo Emanuele Levi Setti, M.D., Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895227
- Sponsor's protocol ID
- 16/23
- Status last verified
- May 2023
- First submitted
- 14 Mar 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cirillo F, Secchi M, Zannoni E, Scolaro V, Immediata V, Morenghi E, Busnelli A, Deaconescu AD, Patrizio P, Levi Setti PE. Hemoperitoneum after oocyte retrieval in women undergoing ART: A 2017-2022 retrospective cohort study with a historical comparison to 1996-2016. Eur J Obstet Gynecol Reprod Biol. 2026 Sep;325:115339. doi: 10.1016/j.ejogrb.2026.115339. Epub 2026 Jul 26.
PubMed 42526230
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.
- ClinicalTrials.gov ID
- NCT05895227
- Acronym / sponsor ID
- 16/23
- Conditions
- ART, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,193 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 8 Jun 2023 (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.
The goal of this retrospective analysis is to focus on peritoneal bleeding after oocyte retrieval and to further investigate factors related to this specific complication and if hemorrhagic complication rate modifications can be observed.
Detailed description
The main aim is to update our knowledge on oocyte retrieval complication, focusing specifically on hemorrhagic / hemoperitoneum rate.
All retrievals will be retrieved in IVF/ICSI cycles and Fertility Preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.
Data collection goes from January 2017 to December 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Patients that underwent oocyte retrieval procedure at Humanitas Fertility Center during the period January 2017 - December 2022, in IVF/ICSI cycles and fertility preservation both in oncological patients and in patients requesting oocyte storage for deferring motherhood.
Key inclusion criteria (1 listed)
- patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation
Key exclusion criteria (1 listed)
- -
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 retrieval | Procedure or surgery | – |
Primary outcome
Hemoperitoneum after oocyte transvaginal retrieval
Time frame: Oocyte retrievals in the period January 2017- December 2022
number of patients with onset of hemoperitoneum
6 secondary outcomes
Operator of the procedure
Time frame: 6 years
Hemoglobin level before and after procedure
Time frame: 6 years
Time of symptoms onset
Time frame: 6 years
Loss of blood during procedure
Time frame: 6 years
Incidence compared to past case history
Time frame: 6 years
Need for hospitalization
Time frame: 6 years
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 8 Jun 2023.
- Derived from this study: PubMed 42526230Cirillo F, Secchi M, Zannoni E, Scolaro V, Immediata V, Morenghi E, Busnelli A, Deaconescu AD, Patrizio P, Levi Setti PE. Hemoperitoneum after oocyte retrieval in women undergoing ART: A 2017-2022 retrospective cohort study with a historical comparison to 1996-2016. Eur J Obstet Gynecol Reprod Biol. 2026 Sep;325:115339. doi: 10.1016/j.ejogrb.2026.115339. Epub 2026 Jul 26.
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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.
Paolo Emanuele Levi Setti, M.D. principal investigator
Istituto Clinico Humanitas
Questions about this trial
What is this clinical trial studying?
An observational study of ART and Infertility, 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 8 Jun 2023. 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?
Hemoperitoneum after oocyte transvaginal retrieval (time frame: Oocyte retrievals in the period January 2017- December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895227, which also lists 1 linked publication.
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 8 Jun 2023.