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

NCT ID: NCT01058603

Last Updated: 2010-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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D3

Group Type ACTIVE_COMPARATOR

- Conventional culture medium for IVF

Intervention Type OTHER

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

D5

Group Type EXPERIMENTAL

- Endocell®

Intervention Type OTHER

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.

Interventions

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- Conventional culture medium for IVF

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Laboratoires Genévrier

INDUSTRY

Sponsor Role lead

Responsible Party

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Laboratoires Genévrier

Locations

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CMCO

Schiltigheim, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Anissa Benoussaidh

Role: CONTACT

+33-492914134

Facility Contacts

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Jeanine Ohl, MD

Role: primary

00 (33)3.88.62.84.34

Other Identifiers

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07F/END01

Identifier Type: -

Identifier Source: org_study_id

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