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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Emmanuelle Mathieu d'Argent, MD
- Telefonnummer: +33 156 01 68 69
- E-mail: emmanuelle.mathieu@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Emile Darai, MD, PhD
- E-mail: emile.darai@tnn.aphp.fr
Studiesteder
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Ile De France
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Paris, Ile De France, Frankrig, 75020
- Rekruttering
- Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
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Kontakt:
- Emmanuelle Mathieu d'Argent, MD
- Telefonnummer: +33 156 01 68 69
- E-mail: emmadargent@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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)
Tidsramme: 5 years
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baseline data
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5 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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rate of patients who will re-use their cryopreserved oocytes
Tidsramme: 5 years
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follow up data
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5 years
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oocytes survival rate
Tidsramme: 5 years
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follow up data
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5 years
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pregnancy rate
Tidsramme: 5 years
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follow up data
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5 years
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birth rate
Tidsramme: 5 years
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follow up data
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5 years
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live birth rate
Tidsramme: 5 years
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follow up data
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5 years
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Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
Tidsramme: 5 years
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Patients complete a SF-36 questionnaire
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5 years
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Events between fertility preservation and re-use or end of the study 1
Tidsramme: 5 years
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Nature of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 2
Tidsramme: 5 years
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Number of surgical procedures for endometriosis during the year
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5 years
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Events between fertility preservation and re-use or end of the study 3
Tidsramme: 5 years
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Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
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5 years
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Events between fertility preservation and re-use or end of the study 4
Tidsramme: 5 years
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Duration of medical treatement for endometriosis during the year: number of months during the year
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5 years
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Events between fertility preservation and re-use or end of the study 5
Tidsramme: 5 years
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Type of medical treatement for endometriosis during the year: class of molecule
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5 years
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Emmanuelle Mathieu d'Argent, MD, Assistance Publique - Hôpitaux de Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- APHP180260
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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