This study will be conducted in infertile women justifying ART (Assisted Reproductive Technology) treatment (only IVF - In Vitro Fecondation) MedDRA version: 9.1 Level: LLT Classification code 10056204 Term: In vitro fertilisation
Conditions
Interventions
Trade Name: GONAL-f 450 IU/0.75 ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Follitropin alfa
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equ
Sponsors
Merck Lipha Santé SAS
Eligibility
Sex/Gender
All
Inclusion criteria
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prior to any study related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care.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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the gene expression profile and histologic changes of endometrial tissue before (at day LH + 7 of spontaneous cycle) and after stimulation with GONAL-f (Day of Oocyte Retrieval (OR): 36 +/- 2 hours post r-hCG administration) in ART (only IVF/no ICSI).;Secondary Objective: To correlate the gene expression profile of the endometrial tissue at Day LH + 7 of the spontaneous cycle with the blastocyst implantation rate in patients undergoing ART with GONAL-f. To correlate the gene expression profile and histologic changes of the endometrial tissue before and after stimulation by GONAL-f with the “down regulation” protocol used (agonist or antagonist). To correlate the gene expression profile and histologic changes of the endometrial tissue before and after stimulation by GONAL-f according to the hormonal status of patients. To characterize the gene expression profile and histology of the endometrial tissue after stimulation with GONAL-f in patients without blastocyst during the theoretical window of implantation (OR + 5 or 6 days) To characterize the gene expression profile and histology of the endometrial tissue of good and poor responders to stimulation with GONAL-f on the Day of OR ;Primary end point(s): A list of genes differentially expressed and histologic changes of endometrial tissue following 1 cycle with GONAL-f. This list will show which genes are affected by GONAL-f through comparison with the gene expression profile of day LH+7 of the previous cycle | — |
Countries
France
Outcome results
None listed