Fertility Preservation in Case of Endometriosis (PREFENDO)
Fertility Preservation in Case of Endometriosis : Observational Cohort Study
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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 :
- information and signatures of consent file ;
- ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures)
- questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies)
- data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Emmanuelle Mathieu d'Argent, MD
- Telefonnummer: +33 156 01 68 69
- E-post: emmanuelle.mathieu@aphp.fr
Studera Kontakt Backup
- Namn: Emile Darai, MD, PhD
- E-post: emile.darai@tnn.aphp.fr
Studieorter
-
-
Ile De France
-
Paris, Ile De France, Frankrike, 75020
- Rekrytering
- Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
-
Kontakt:
- Emmanuelle Mathieu d'Argent, MD
- Telefonnummer: +33 156 01 68 69
- E-post: emmadargent@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- women from 18 to 36 years old
- endometriosis disease proved by sonography, MRI and/or surgery
- Consenting to participate to the study
Exclusion Criteria:
- Any contraindication for ovarian stimulation.
- Any contraindication for pregnancy .- Impossible Follow-up.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
Women with endometriosis
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)
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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)
Tidsram: 5 years
|
baseline data
|
5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
rate of patients who will re-use their cryopreserved oocytes
Tidsram: 5 years
|
follow up data
|
5 years
|
|
oocytes survival rate
Tidsram: 5 years
|
follow up data
|
5 years
|
|
pregnancy rate
Tidsram: 5 years
|
follow up data
|
5 years
|
|
birth rate
Tidsram: 5 years
|
follow up data
|
5 years
|
|
live birth rate
Tidsram: 5 years
|
follow up data
|
5 years
|
|
Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
Tidsram: 5 years
|
Patients complete a SF-36 questionnaire
|
5 years
|
|
Events between fertility preservation and re-use or end of the study 1
Tidsram: 5 years
|
Nature of surgical procedures for endometriosis during the year
|
5 years
|
|
Events between fertility preservation and re-use or end of the study 2
Tidsram: 5 years
|
Number of surgical procedures for endometriosis during the year
|
5 years
|
|
Events between fertility preservation and re-use or end of the study 3
Tidsram: 5 years
|
Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
|
5 years
|
|
Events between fertility preservation and re-use or end of the study 4
Tidsram: 5 years
|
Duration of medical treatement for endometriosis during the year: number of months during the year
|
5 years
|
|
Events between fertility preservation and re-use or end of the study 5
Tidsram: 5 years
|
Type of medical treatement for endometriosis during the year: class of molecule
|
5 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Emmanuelle Mathieu d'Argent, MD, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- APHP180260
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .