PREFENDO: Fertility Preservation in Case of Endometriosis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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 :
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information and signatures of consent file ;
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ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures)
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questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies)
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data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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) |
Outcome Measures
Primary Outcome Measures
- 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) [5 years]
baseline data
Secondary Outcome Measures
- rate of patients who will re-use their cryopreserved oocytes [5 years]
follow up data
- oocytes survival rate [5 years]
follow up data
- pregnancy rate [5 years]
follow up data
- birth rate [5 years]
follow up data
- live birth rate [5 years]
follow up data
- Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire [5 years]
Patients complete a SF-36 questionnaire
- Events between fertility preservation and re-use or end of the study 1 [5 years]
Nature of surgical procedures for endometriosis during the year
- Events between fertility preservation and re-use or end of the study 2 [5 years]
Number of surgical procedures for endometriosis during the year
- Events between fertility preservation and re-use or end of the study 3 [5 years]
Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)
- Events between fertility preservation and re-use or end of the study 4 [5 years]
Duration of medical treatement for endometriosis during the year: number of months during the year
- Events between fertility preservation and re-use or end of the study 5 [5 years]
Type of medical treatement for endometriosis during the year: class of molecule
Eligibility Criteria
Criteria
Inclusion Criteria:
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women from 18 to 36 years old
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endometriosis disease proved by sonography, MRI and/or surgery
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Consenting to participate to the study
Exclusion Criteria:
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Any contraindication for ovarian stimulation.
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Any contraindication for pregnancy .- Impossible Follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON | Paris | Ile De France | France | 75020 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Emmanuelle Mathieu d'Argent, MD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP180260