An observational study in Endometriosis, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to female participants aged 18 Years to 36 Years. Per ClinicalTrials.gov, last updated 2019-03-05.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.
We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.
Monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes.
Protocol of this study :
925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's planned enrollment of 100 is below the median of 125 across 354 observational studies indexed under Endometriosis.
Browse Endometriosis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients suffering from endometriosis, referred to our tertiary care university hospital for fertility preservation, from 18 to 36 years old.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Women with endometriosis disease aged 18-36 years, with appropriate endometriosis diagnosis, based on transvaginal sonography, magnetic resonance imaging and/or previous surgery.Ovarian reserve was assessed by antral follicle counting (AFC) and measurement of serum anti-Mullerian hormone (AMH) levels Enrolled after preservation fertility procedure (vitrification of mature oocytes)
characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
baseline data
Time frame: 5 years
rate of patients who will re-use their cryopreserved oocytes
follow up data
Time frame: 5 years
oocytes survival rate
follow up data
Time frame: 5 years
pregnancy rate
follow up data
Time frame: 5 years
birth rate
follow up data
Time frame: 5 years
live birth rate
follow up data
Time frame: 5 years
Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
Patients complete a SF-36 questionnaire
Time frame: 5 years
Events between fertility preservation and re-use or end of the study 1
Nature of surgical procedures for endometriosis during the year
Time frame: 5 years
Events between fertility preservation and re-use or end of the study 2
Number of surgical procedures for endometriosis during the year
Time frame: 5 years
Events between fertility preservation and re-use or end of the study 3
Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
Time frame: 5 years
Events between fertility preservation and re-use or end of the study 4
Duration of medical treatement for endometriosis during the year: number of months during the year
Time frame: 5 years
Events between fertility preservation and re-use or end of the study 5
Type of medical treatement for endometriosis during the year: class of molecule
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Dec 2020, 24 months after the start.
Of 153 non-industry observational studies under Endometriosis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 24 months is below that.
Counting every sponsor, half of 182 studies reached it within 30 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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