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

Phase 1

• Conditions: This study will be conducted in infertile women justifying ART (Assisted Reproductive Technology) treatment (only IVF - In Vitro Fecondation); MedDRA version: 9.1Level: LLTClassification code 10056204Term: In vitro fertilisation

• Registration Number: EUCTR2007-003938-41-FR
• Lead Sponsor: Merck Lipha Santé SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-08-28
• Study Completion: 2010-08-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 0

Inclusion Criteria

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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
Known allergic reaction or hypersensitivity to GONAL-f or to Ovitrelle
Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years
Participation within 3 months prior to study entry in another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified