Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
NCT ID: NCT01058603
Last Updated: 2010-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
720 participants
INTERVENTIONAL
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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D3
- Conventional culture medium for IVF
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
D5
- Endocell®
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.
Interventions
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- Conventional culture medium for IVF
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
- Endocell®
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
36 Years
FEMALE
No
Sponsors
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Laboratoires Genévrier
INDUSTRY
Responsible Party
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Laboratoires Genévrier
Locations
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CMCO
Schiltigheim, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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07F/END01
Identifier Type: -
Identifier Source: org_study_id
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