Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility

Study Overview
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Brief Summary
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The aim of this study is to demonstrate the efficacy of a single embryo transfer at blastocyst stage (Day 5) after co-culture on Autologous Endometrial Cell Culture (AECC) versus transfer of a single embryo at Day 3 after culture in conventional medium. Efficacy will be assessed in terms of clinical pregnancy rate 5 to 8 weeks after embryo transfer.

Official Title
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Multicentre, Randomised, Controlled Clinical Study on the Efficacy in Terms of Clinical Pregnancy Rate of 1 Embryo Transfer at Day 5 After Co-culture on Autologous Endometrial Cells(ENDOCELL®) Versus 1 Embryo Transfer at Day 3 After Culture on Conventional Medium.

Conditions
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Infertility

Intervention / Treatment
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* Other: - Conventional culture medium for IVF
* Other: - Endocell®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥ 18 and ≤ 36 Undergoing ovarian stimulation for an In Vitro Fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) Having experienced no more than 1 Embryo Transfer failure With basal FSH level ≤ 12 IU/l within the 6 months prior to the study Endometrial biopsy during the menstrual cycle preceding the ovarian stimulation (6 to 12 days after a documented ovulation) Negative serology for HIV 1 and 2, hepatitis B and C, HTLV 1 and 2, syphilis Exclusion Criteria: Hypersensitivity to one of the culture media components Oocyte donation, sperm donation Thawed embryos transfer Women with endometriosis grade III and IV, chronic endometritis, hydrosalpinx, polycystic ovary, amenorrhoea, anovulation, uterus with malformation, uncontrolled prolactinaemia, uterine synechia, uterine fibroma, women exposed to distilbene, uterine polyps Women affected by pathologies associated with any contraindication of being pregnant Abnormal gynaecologic bleeding of undetermined origin Uncontrolled thyroid (TSH dosage) or adrenal dysfunction Neoplasias, any pathologies of the endometrium or the cervix

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D3<br> | Other: - Conventional culture medium for IVF<br>* Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen<br>|
| Experimental: D5<br> | Other: - Endocell®<br>* Embryos are cultured on ENDOCELL® from Day 2 to Day 5 (Blastocyst stage) One embryo is transferred at Day 5. Supernumerary good quality embryos are frozen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infertility, Cell Culture, AECC, Endocell, IVF