prevent premature luteinitation MedDRA version: 20.0 Level: PT Classification code 10072070 Term: Oocyte donor System Organ Class: 10041244 - Social circumstances
Conditions
Interventions
Trade Name: ORGALUTRAN
Pharmaceutical Form: Injection
INN or Proposed INN: GANIRELIX
Other descriptive name: GANIRELIX
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numbe
Sponsors
INSTITUTO VALENCIANO DE INFERTILIDAD (IVI)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female subjects between 18-35 years old - No personal or family history of interest - Sign Informed Consent - From the medical point of view: Body mass index between 18-28 kg / m2 Uterus and normal ovaries, without organic pathology Non-polycystic ovaries Count of antral follicles> 12 in the sum of the two ovaries Normal karyotype Negative screening for infectious diseases (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis) General Analytic with hemogram, hemostasis and biochemistry with parameters within normality. 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 318 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Simultaneous participation in another clinical study - Participation in another clinical study 2 months before inclusion in the present study that could affect the objectives of the study - Any systemic or metabolic disorder that contraindicates the use of gonadotrophins. - History of thrombophlebitis and thromboembolic phenomena and HT - Known hypersensitivity to AMP or its excipients - Any motive that implies exclusion from the oocyte donation program - Suspect or evidence of mammary malignancy or hormone-dependent genitalia - Known infection with human immunodeficiency virus, active virus of hepatitis B or C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the number of oocytes and metaphase II oocytes (MII) from donors that have received ovarian stimulation with FSHr and in which it has been used to an antagonist of GnRH vs AMP for prevent early luteinization.;Secondary Objective: To compare Clinical results in donor: • Incidence of early luteinization. • OHSS (Ovarian hyperstimulation syndrome) incidence. • Days of stimulation and dose of gonadotropins administered • Comparison of side effects between both protocols in donors • Analysis of serum hormone profile: estradiol, progesterone and LH - Cost of each protocol - Convenient employment for donors (Evaluate the degree of satisfaction of donors according to the protocol used);Primary end point(s): Number of oocytes Metaphase II and mature oocyte rate;Timepoint(s) of evaluation of this end point: Before embryo-transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence of early luteinization • SHO incidence • Area under the curve of serum estradiol during ovarian stimulation • Area under the serum progesterone curve during ovarian stimulation • Area under the serum LH curve during ovarian stimulation • Concentration of P4 in follicular fluid • Estradiol concentration in follicular fluid Concentration of FSH in follicular fluid • Concentration of LH in follicular fluid • Cost of each protocol • Convenience of employment for donors;Timepoint(s) of evaluation of this end point: During the ovarian stimulation | — |
Countries
Spain
Contacts
Public ContactJuan Giles
INSTITUTO VALENCIANO DE INFERTILIDAD (IVI)
Outcome results
None listed