Efficacy of Endocell® vs Conventional Medium in the Treatment of Infertility

L

Laboratoires Genévrier

Status and phase

Unknown
Phase 3

Conditions

Infertility

Treatments

Other: - Conventional culture medium for IVF
Other: - Endocell®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01058603
07F/END01

Details and patient eligibility

About

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.

Enrollment

720 estimated patients

Sex

Female

Ages

18 to 36 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

720 participants in 2 patient groups

D3
Active Comparator group
Treatment:
Other: - Conventional culture medium for IVF
D5
Experimental group
Treatment:
Other: - Endocell®

Trial contacts and locations

1

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Central trial contact

Anissa Benoussaidh

Data sourced from clinicaltrials.gov

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