NCT07437742

Brief Summary

The study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

October 15, 2024

Last Update Submit

February 24, 2026

Conditions

Keywords

fertilityendometriosissurgeryPMA

Outcome Measures

Primary Outcomes (1)

  • endometriosis and PMA

    Compare the number of women who undergo PMA after medical treatment with those who undergo PMA after surgery, then compare these data with those reported in the literature

    2012 to 2021 diagnosis

Interventions

PMAOTHER

use of Medically assisted procreation techniques (PMA)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women with endometriosis with an ultrasound or surgical diagnosis of endometriosis in one of the centres participating in the study who sought a pregnancy after diagnosis at an age of less than 40 years. The number of patients required will be approximately 650 in order to detect an absolute difference of ≥10% between the two groups ( medical or surgery terapy)..

You may qualify if:

  • age \<40 years at the time of offspring research
  • previous ultrasound or surgical diagnosis of endometriosis made in one of the endometriosis referral centres participating in the study
  • search for offspring after diagnosis
  • consent to the use of pseudonymised data for research purposes.

You may not qualify if:

  • women without endometriosis
  • age \>=40 years at the time of the search for offspring
  • women who have undergone demolition surgery
  • women who do not wish to have offspring
  • women who have not given consent for their pseudonymised data to be used for research purposes
  • severe male infertility factor (testicular sperm retrieval)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italia, 20077, Italy

RECRUITING

Related Publications (1)

  • Somigliana E, Daguati R, Vercellini P, Barbara G, Benaglia L, Crosignani PG. The use and effectiveness of in vitro fertilization in women with endometriosis: the surgeon's perspective. Fertil Steril. 2009 May;91(5):1775-9. doi: 10.1016/j.fertnstert.2008.02.004. Epub 2008 Apr 3.

Related Links

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Nicola Dr Berlanda, principal investigator

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

October 15, 2024

First Posted

February 27, 2026

Study Start

October 1, 2024

Primary Completion

March 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations