Open label pilot study on gene expression profiling of the endometrial tissue in patients undergoing Assisted Reproductive Technology (ART: only IVF) with GONAL-f. - Express study

Merck Lipha Santé SAS0 sites0 target enrollmentAugust 28, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 28, 2007

End Date

August 30, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Merck Lipha Santé SAS

•Infertile female with diverse infertility aetiologies including tubal disease (excepting hydrosalpynx) and so called unexplained infertility”
•Suitable for ART (only IVF, no ICSI), undergoing first or second attempt\- 18\-35 years old, normal BMI (£ 25\), non smoking
•Normal ovarian status (FSH, E2, AMH 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 Papanicolau test within the last 12 months prior to study entry
•No hormonal therapy, including gonadotropins, for at least 3 months prior to the study
•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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contra\-indication to pregnancy or carrying pregnancy to term
•Uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia
•History of previous ovarian hyperstimulation syndrome (OHSS)\- PCOS according to the revised Rotterdam Consensus 2003
•Extra\-uterine pregnancy during the previous 3 months\-Recurrent miscarriages (early or late, more than 2\)
•Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus, for subject or partner
•Abnormal gynaecological bleeding of undetermined origin
•History of major thromboembolic disease
•Endometriosis
•Presence or history of malignant tumours and related treatment
•Clinically significant systemic disease or clinically significant abnormal haematology, chemistry, or urinalysis results at screening