Clincosm LogoSign in Get a demo

Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.

Sponsor
Istituto Clinico Humanitas (Other)
Overall Status
Completed
CT.gov ID
NCT05895227
Collaborator
(none)
13,193
Enrollment
71.6
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Oocyte retrieval

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

Study Type:
Observational
Actual Enrollment :
13193 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Hemorrhagic Complications of Transvaginal Oocyte's Retrieval: an Update.
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 21, 2022
Actual Study Completion Date :
Dec 21, 2022

Outcome Measures

Primary Outcome Measures

  1. Hemoperitoneum after oocyte transvaginal retrieval [Oocyte retrievals in the period January 2017- December 2022]

    number of patients with onset of hemoperitoneum

Secondary Outcome Measures

  1. Operator of the procedure [6 years]

    assessment of operator experience

  2. Hemoglobin level before and after procedure [6 years]

    evaluation of hemoglobin level before and the day after procedure

  3. Time of symptoms onset [6 years]

    evaluation of first symptoms onset

  4. Loss of blood during procedure [6 years]

    average blood loss

  5. Incidence compared to past case history [6 years]

    comparison with previous statistic

  6. Need for hospitalization [6 years]

    patients requiring hospitalisation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Inclusion Criteria:
  • patients that underwent a procedure of oocyte transvaginal retrieval for IVF/ intracytoplasmatic sperm injection (ICSI) cycles and fertility preservation
Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Paolo Emanuele Levi Setti, M.D., Istituto Clinico Humanitas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT05895227
Other Study ID Numbers:
  • 16/23
First Posted:
Jun 8, 2023
Last Update Posted:
Jun 8, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility

Study Results

No Results Posted as of Jun 8, 2023