Status:
TERMINATED
EXpression PRofile Endometrium Samples Study
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A.S, France
Conditions:
In Vitro Fertilization
Eligibility:
FEMALE
18-35 years
Phase:
PHASE4
Brief 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 wit...
Detailed Description
This is a pilot open-label, national, multi-centre, Phase IV trial. This trial will be conducted with outpatients. Once subject has met all eligibility criteria, she will be treated with Gonal-f® pref...
Eligibility Criteria
Inclusion
- 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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01210144
Start Date
August 1 2008
End Date
August 1 2010
Last Update
December 27 2013
Active Locations (1)
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1
Research Site
Paris, France