infertility.
Conditions
Interventions
Intervention 1: This is a multicentre, multi-national, randomized,
open-label comparative trial
At the screening visit, the prospective subject will be
informed of the trial objectives and overall
req
300 IU per day) stimulation day 1-5 then add Luveris® (vial/powder, 300 IU per day) from stimulation day 6 and until required r-hCG level is met. The dose can be adjusted from stimulation day 6 (incre
Treatment - Drugs
This is a multicentre, multi-national, randomized,
open-label comparative trial
At the screening visit, the prospective subject will be
informed of the trial objectives and overall
requirements. I
300 IU per day) stimulation day 1-5 then add Luveris® (vial/powder, 3
GONAL-f® (Liquid Pen
300 IU of per day) stimulation day 1-5 then followed by Luveris® (vial/powder, 300 IU per day) from stimulation day 1 and until required r-hCG level is met. The dose can be adjusted from stimulation
Sponsors
Merck soreno
Eligibility
Sex/Gender
Female
Age
36 Years to 42 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: • Infertile patients aged >35 years to <= 42 • Basal FSH < 12 IU/L • BMI < 32 kg/m2 • Regular menstrual cycles between 21-35 days • Receiving daily sc long GnRH agonist protocol - day 21 until day of hCG No ovarian stimulation of any kind during the previous 3 months. Exclusion Criteria: Subjects are not eligible for this trial if they fulfil any of the following exclusion criteria Had = 2 previous ART cycles with a poor response to gonadotrophin stimulation defined as = 6 mature follicles and/or?= 4 oocytes collected in any previous IVF cycle or previous cycles with a hyper response defined as?= 25 oocytes retrieved, Any medical condition, which in the judgment of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with GONAL-F® Medical responsible, Had previous severe OHSS Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS, Presence of endometriosis requiring treatment, Uterine myoma requiring treatment, Any contraindication to being pregnant and/or carrying a pregnancy to term, Extra-uterine pregnancy within the last 3 months prior to screening, History of 3 or more miscarriages (early or late miscarriages) due to any cause, Tumours of the hypothalamus and pituitary gland, Ovarian enlargement or cyst of unknown aetiology, Ovarian, uterine or mammary cancer, A clinically significant systemic disease, Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner, • Abnormal gynecological bleeding of undetermined origin, • Known allergy or hypersensitivity to human gonadotrophin preparations, • Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years prior to the screening visit, • Entered previously into this trial or simultaneous Participation in another clinical trial. • Pregnancy and lactation period • Participation in another clinical trial within the past 30 days
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of oocytes retrieved per subject. Timepoint: 10-15 days. Method of measurement: Utrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Implantation rate. Timepoint: 10-15 day. Method of measurement: Ultrasonography.;Total dose of FSH used (in IU). Timepoint: 10-15 day. Method of measurement: Serum and lab.;Total number of stimulation treatment days. Timepoint: 10-15 day. Method of measurement: Serum and lab. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMarjan Ghaemi
Farzan Clinical Research Institute
Outcome results
None listed