EXpression PRofile Endometrium Samples Study

• Status: Terminated
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest.

The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.A.S, France
• Treatments: Chorionic Gonadotropin; Follicle Stimulating Hormone; Hormones; Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Infertile female or infertile male. Infertile female means diverse infertility etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained infertility"

• Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first attempt

• 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square meter (kg/m^2), non smoking

• Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter [IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal laboratory range values, normal ovaries sonography and uterine echo doppler)

• No history of active genito-urinary infection

• Normal thyroid function (or adequate substitution for at least 3 months)

• Negative cervical papanicolaou test within the last 12 months prior to study entry

• No hormonal therapy, including gonadotropins and progesterone, for at least 2 months prior to the study

• In couple with female infertility, male partner with normal sperm or moderate oligoasthenospermia in semen analysis and negative semen culture less than 6 months at the study entry

• Willingness and ability to comply with the protocol for the duration of the study

• Written informed consent prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care

Exclusion Criteria:

• Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term

• Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia

• Subjects with history of previous OHSS

• Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam Consensus 2003

• Subjects with extra-uterine pregnancy during the previous 3 months

• Subjects with recurrent miscarriages (early or late, more than 2)

• Subjects having known infection with human immunodeficiency virus (HIV), hepatitis B or C virus, for subject or partner

• Subjects with abnormal gynecological bleeding of undetermined origin

• Subjects with history of major thromboembolic disease

• Subjects with endometriosis

• Subjects with presence or history of malignant tumors and related treatment

• Subjects with clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening

• Subjects with known allergy or hypersensitivity to Gonal-f® or Ovitrelle®

• Subjects with any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years

• Subjects who have participated within 3 months prior to study entry in another clinical trial