Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
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.
1 other identifier
interventional
720
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
January 28, 2010
CompletedFebruary 4, 2010
February 1, 2010
January 27, 2010
February 3, 2010
Conditions
Keywords
Study Arms (2)
D3
ACTIVE COMPARATORD5
EXPERIMENTALInterventions
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMCO
Schiltigheim, 67303, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 27, 2010
First Posted
January 28, 2010
Study Start
February 1, 2008
Last Updated
February 4, 2010
Record last verified: 2010-02