EXpression PRofile Endometrium Samples Study
Condition: In Vitro Fertilization
Intervention: Gonal -f® [r-hFSH]; Ovitrelle® [r-hCG alfa]; Gonadotropin-releasing hormone (GnRH) Agonist; Gonadotropin-releasing hormone (GnRH) Antagonist
Intervention description: On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.; Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.; To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.; To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
Intervention MeSH terms: Chorionic Gonadotropin; Hormones; Prolactin Release-Inhibiting Factors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Infertility; Gonal-f; gene expression; Assisted Reproductive Technologies; Follitropin alfa; endometrium

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.
    

Eligibility 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