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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058603

Enrollment

720

Registered

2010-01-28

Start date

2008-02-29

Completion date

Unknown

Last updated

2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Infertility, Cell Culture, AECC, Endocell, IVF

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.

Interventions

OTHER- Conventional culture medium for IVF

Embryos are cultured on conventional medium and transferred at Day 3. Supernumerary good quality embryos are frozen

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

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

Countries

France

Contacts

Primary ContactAnissa Benoussaidh

abenoussaidh@laboratoires-genevrier.com+33-492914134

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026