Back to resultsEfficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
Primary Purpose
Infertility
Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
- Conventional culture medium for IVF
- Endocell®
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Infertility, Cell Culture, AECC, Endocell, IVF
Eligibility Criteria
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
Sites / Locations
- CMCORecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
D3
D5
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01058603
First Posted
January 27, 2010
Last Updated
February 3, 2010
Sponsor
Laboratoires Genévrier
1. Study Identification
Unique Protocol Identification Number
NCT01058603
Brief Title
Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Laboratoires Genévrier
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, Cell Culture, AECC, Endocell, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
D3
Arm Type
Active Comparator
Arm Title
D5
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
- Conventional culture medium for IVF
Intervention Description
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
Intervention Type
Other
Intervention Name(s)
- Endocell®
Intervention Description
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anissa Benoussaidh
Phone
+33-492914134
Email
abenoussaidh@laboratoires-genevrier.com
Facility Information:
Facility Name
CMCO
City
Schiltigheim
ZIP/Postal Code
67303
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanine Ohl, MD
Phone
00 (33)3.88.62.84.34
Email
Jeanin.OHL@sihcus.fr
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
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