Sterility MedDRA version: 18.0 Level: LLT Classification code 10042012 Term: Sterility System Organ Class: 100000004872
Conditions
Interventions
Trade Name: OVOPLEX
Product Name: Ovoplex
Product Code: 52574
Pharmaceutical Form: Tablet
INN or Proposed INN: LEVONORGESTREL
CAS Number: 797-63-7
Concentration unit: µg microgram(s)
Concentration ty
Sponsors
IDIPAZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients belong to La Paz University Hospital, Human reproductive service that begin a GnRH antagonist FIV-ICSI cycle. -Patients between 18-40 years diagnosed of primary sterility for several causes like male factor, tubal factor, endometriosis of low grade and low ovarian reserve. -Patients with a BMI =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Endometriosis high grade -Endometrial pathology or uterine malformations previously diagnosed -Ovarian polycystic syndrome according to Rotterdam criteria -Presence of hydrosalpinx -Intolerance or allergy to some drug -Severe male factor (<100.000 REM or severe oligoasthenozoospermia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparing gestational outcomes like pregnancy rate, clinical pregnancy rate, miscarriage rate or live birth rate between patients pretreated with estrogen pills, contraceptive pills and no pretreated .;Secondary Objective: -To evaluate cancellation rate in order to insufficient ovarian stimulation in each group -To evaluate adverse effects like hyperstimulation ovarian syndrome in each group -To evaluate the number of ovarian follicles observed by US and the number of ovocytes obtained after puncture, as well as ovocyte quality in the different study groups. -To observe hormonal basal values of FSH and estradiol before to ovarian stimulation and the possible effect over gestational outcomes. -To observe hormonal values of E2 and Progesterone previously to ovulation induction, and the potential effect over endometrial receptiveness and implantation rates -To evaluate treatment days and gonadotropin total doses necessary to get ovarian stimulation in each group. ;Primary end point(s): Gestational outcomes like pregnancy rate per cycle, clinical pregnancy rate per cycle, clinical miscarriage rate per cycle, live birth rate per cycle.;Timepoint(s) of evaluation of this end point: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Cancellation rate -Hyperstimulation ovarian syndrome -Hormonal basal values of FSH and Estradiol -Hormonal values of E2 and Progesterone previously to ovulation induction -Ovarian follicles observed after ovarian stimulation -Ovocytes obtained after puncture, number of embryo complex and embryo quality -Gonadotropin total doses used to get ovarian stimulation -Total treatment days with gonadotropins -Endometrial thickness before the embryo transfer. ;Timepoint(s) of evaluation of this end point: 2 months | — |
Countries
Spain
Contacts
Public ContactSara Fernandez
Servicio de Reproduccion Humana- H. la Paz
Outcome results
None listed