ovarian stimulation in poor ovarian responders MedDRA version: 20.0 Level: LLT Classification code 10071130 Term: Controlled ovarian stimulation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: LUVERIS 75 UI, POLVO Y DISOLVENTE PARA SOLUCION INYECTABLE
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: LUTROPIN ALFA
CAS Number: 152923-57-4
Ot
Sponsors
IVI Alicante
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.- The current trial will include patients with POR according to specific criteria that are in line with the criteria defined by the ESHRE (Bologna Criteria), according to which a patient is classified as a poor ovarian responder when she meets two of the three of the following criteria: I.- Previous episode of POR (> or = 3 oocytes) with conventional stimulation protocol. II.- Abnormal ovarian reserve test with an antral follicle count (AFC) or = 40 years old* and/or who have any other risk factor for POR. In addition, two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ovarian reserve test. 2. Women > or = 35 to or = 5 mill spermatozoa/mL and > or = 5 mill total spermatozoa progressive motility. Bank and cryopreserved semen allowed. 6.- Informed consent completed, signed and dated. 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 88 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.- Cases of recurrent spontaneous miscarriage (=2 clinical miscarriages) or implantation failure (after transfer of 6 good D3 embryos or 4 good blastocysts) will be excluded 2.- Use of testicular or epididymal spermatozoa as well as ejaculate with concentration < 5 mill spermatozoa/mL and < 5 mill total spermatozoa progressive motility 3.- Primary ovarian failure, PCOS (in accordance with the Rotterdam criteria) or ovary/s inaccessible for oocyte retrieval. 4.– Anatomical uterine abnormalities and any endometrium or myometrium pathology (adenomyosis, polyps, myoma, etc.) that may interfere with implantation or pregnancy. Patients with previous polypectomy, myomectomy or surgery for septate/subseptate/arcuatus uterus should not be excluded. 5.- Presence of unilateral or bilateral hydrosalpinx that has not been surgically removed or ligated. 6.- Presence of level III-IV endometriosis. 7.- History of tumours in the hypothalamus or pituitary gland, or ovarian, uterine or breast cancer. 8.- Abnormal bleeding of undetermined origin. 9.- Known infection with human immunodeficiency virus, active hepatitis B or C virus in the woman or her partner. 10.- Known allergy or hypersensitivity to the drugs administered during the trial. 11.- Concurrent significant medical pathologies that would endanger the patient's safety (uncontrolled thyroid or adrenal dysfunction, severe hepatic or renal impairment, etc.) or interfere with the test evaluations or the clinical outcomes (i.e. confirmed thrombophilia). 12.- Use of concomitant medication or any other circumstances that, in the opinion of the investigator, interferes with the development of the trial or does not ensure the safety and efficacy of the data. 13.- Simultaneous participation in another clinical trial or previous participation in this study. 14.- Participation in another clinical study two months before inclusion in the present study that could affect its objectives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the number of oocytes retrieved in poor ovarian responders with advanced maternal age treated with rLH prior to the controlled ovarian stimulation protocol.;Secondary Objective: - Comparative analysis of the stimulation cycle - Comparative analysis of oocyte quality parameters - Comparative analysis of embryonic quality parameters - Comparative analysis of clinical results in terms of reproductive success - Assessment and recording of adverse events;Primary end point(s): number of oocytes retrieved;Timepoint(s) of evaluation of this end point: Visit 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Variables related to the stimulation cycle Variables related to oocyte quality Variables related to embryo quality Variables of clinical success;Timepoint(s) of evaluation of this end point: - stimulation cycle: after the routine assisted reproduction procedures - oocyte quality: after the routine assisted reproduction procedures performed in the IVF laboratory - embryo quality: during the days of embryonic development in the IVF laboratory - clincal success: after the routine assisted reproduction procedures | — |
Countries
Spain
Contacts
Public ContactDr. Manuel Muñoz
IVI Alicante
Outcome results
None listed