Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Laboratoires Genévrier.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Laboratoires Genévrier
Information provided by:
Laboratoires Genévrier
ClinicalTrials.gov Identifier:
NCT01058603
First received: January 27, 2010
Last updated: February 3, 2010
Last verified: February 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Other: - Conventional culture medium for IVF Other: - Endocell® |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Laboratoires Genévrier:
| Estimated Enrollment: | 720 |
| Study Start Date: | February 2008 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: D3 |
Other: - Conventional culture medium for IVF
Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen
|
| Experimental: D5 |
Other: - 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| Ages Eligible for Study: | 18 Years to 36 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058603
Contacts
| Contact: Anissa Benoussaidh | +33-492914134 | abenoussaidh@laboratoires-genevrier.com |
Locations
| France | |
| CMCO | Recruiting |
| Schiltigheim, France, 67303 | |
| Contact: Jeanine Ohl, MD 00 (33)3.88.62.84.34 Jeanin.OHL@sihcus.fr | |
Sponsors and Collaborators
Laboratoires Genévrier
More Information
No publications provided
| Responsible Party: | Laboratoires Genévrier |
| ClinicalTrials.gov Identifier: | NCT01058603 History of Changes |
| Other Study ID Numbers: | 07F/END01 |
| Study First Received: | January 27, 2010 |
| Last Updated: | February 3, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Laboratoires Genévrier:
|
Infertility Cell Culture AECC Endocell IVF |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013