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Recruiting NCT07437742

Reproductive Prognosis in Women Seeking Offspring After Medical or Surgical Therapy for Endometriosis

Observational Endometriosis Fertility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PMA.
Who it may be relevant to
Registry conditions: Endometriosis, Fertility. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

La Prognosi Riproduttiva Nelle Donne Che Ricercano Prole Dopo Terapia Medica o Chirurgica Per Endometriosi: Studio Multicentrico Italiano

Overview

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.

Detailed description

The objective of the study is to compare how many women with endometriosis undergo PMA after medical treatment and how many after surgical treatment , then compare these data with those reported in the literature. Secondary objectives will be to describe the mode of conception ande pregnancy rate and to compare the pregnancy rate from post-surgical PMA observed in the present Italian multicenter study with that observed in the previous single-center study conducted at the Foundation. This will allow to evaluate the impact of 15 years of evolution of surgical and PMA techniques on the reproductive prognosis of women operated for endometriosis and to expand the observation to the whole Italian territory.

Interventions

  • Other PMA
    use of Medically assisted procreation techniques (PMA)

Primary outcome measures

  • endometriosis and PMA [Time frame: 2012 to 2021 diagnosis]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan

Publications

  • 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. PMID 18394620

Identifiers

NCT: NCT07437742 · 4291

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗