Infertility. Assisted Reproductive Techniques. Fresh donated oocyte recipients MedDRA version: 17.1 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: PROLUTEX 25 mg solución inyectable
Pharmaceutical Form: Solution for injection
Trade Name: PROGEFFIK 200 mg cápsulas blandas
Product Name: Progeffik 200 mg
Pharmaceutical Form: Capsule, s
Sponsors
Instituto Bernabeu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female age between 18 and 49 years (inclusive) Women who want pregnancy Endometrial thickness greater than 7 mm on the randomization of the patient is made to a group of progesterone more than 6 oocytes retrieved from the donor woman Patient scheduled for fresh embryo transfer on day +5 embryo culture BMI greater than 30 kg / m2 Infertility justify treatment with donor oocytes Women Males no known alterations in karyotype Semen ejaculation from either the partner or from bank Uterus able to support embryo implantation and pregnancy Absence of pregnancy before starting the cycle of embryo transfer Have consented in writing 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 120 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Important endocrine-metabolic Systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney Seropositivity for HIV, HBV or HCV Undiagnosed vaginal bleeding Pregnancy, lactation or contraindication for pregnancy Malformations of sexual organs incompatible with pregnancy Known allergy to preparations of progesterone or its excipients Current dependence on alcohol, drugs or psychotropic Concurrent participation in another study Concomitant medication that could interfere with study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the impact on the rate of ongoing pregnancy at 12 weeks with the use of subcutaneous progesterone or vaginal progesterone capsules for endometrial preparation in fresh donated oocyte recipients;Secondary Objective: Serum progesterone thickness and morphology of endometrium implantation rate rate of biochemical pregnancy beta-hCG test positive clinical pregnancy rate abortion rate tolerability progesterone comfort relative to its route of administration;Primary end point(s): rate of ongoing pregnancy at 12 weeks;Timepoint(s) of evaluation of this end point: ten weeks of progesterone treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): serum progesterone level endometrial thickness and morphology implantation rate rate of biochemical pregnancy beta-hCG test positive clinical pregnancy rate abortion rate tolerability progesterone comfort relative to its route of administration;Timepoint(s) of evaluation of this end point: serum progesterone level on the day of transfer (day 0) and day of biochemical beta-hCG pregnancy test (+14 days) thickness and morphology of endometrium on the day of oocyte collection (day 0) and day of embryo transfer (+5 days) implantation rate (+14 days) rates of biochemical pregnancy beta-hCG test positive (+14 days) clinical pregnancy rate (4 or 5 weeks) abortion rate (4 to 5 weeks) tolerability (+5 days +14 days, + 4-5 weeks weeks treatment +10) comfort of progesterone in relation to the route of administration (days +5, +14 days, +10 weeks of treatment) | — |
Countries
Spain
Contacts
Public ContactMedicina Reproductiva
Instituto Bernabeu
Outcome results
None listed