Diminished Ovarian Reserve
Conditions
Interventions
This is an open label randomized non inferiority clinical trial with parallel allocation of two hundred participants being one hundred participants in the experimental group and one hundred participan
Patient-Oriented Strategies Encompassing Individualized Oocyte Number"
group three and four generated by an independent statistician The study is open label that is without masking for participants and researchers Experimental group Progesterone participants will receive
Sponsors
Hospital de Clínicas de Porto Alegre
Clínica Proser
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Age between 18-45 years; Female gender; Patients undergoing their first PPOS protocol who meet the criteria for POSEIDON group 3 (women <35 years old with low ovarian reserve, AFC<5) or POSEIDON group 4 (women =35 years old with low ovarian reserve, AFC<5); Indication for in vitro fertilization or intracytoplasmic sperm injection; Signed informed consent
Exclusion criteria
Exclusion criteria: Chromosomal abnormalities in either partner; Oocyte cryopreservation, oocyte or sperm donation; Endometrioma (= 3 cm on imaging); Combined transfer of embryos from different stimulation cycles; Contraindication to the use of progesterone or clomiphene
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the ovulation inhibition rate in cycles with Clomiphene versus Progesterone; verified by comparing the proportions of premature LH surge blockade between the groups; the outcome will be measured by confirming that the inhibition rate in the Clomiphene group is not inferior by more than 7% to the Progesterone group | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the cumulative live birth rate per follicular aspiration cycle; verified by monitoring patients and their records for 24 months; The live birth rate will be compared between the Progesterone and Clomiphene groups ;To compare the number of oocytes retrieved; verified by counting oocytes after follicular aspiration in the laboratory; The mean number of oocytes will be compared between the groups;To assess the oocyte maturation rate; verified by counting mature oocytes (MII) in the embryology laboratory; The MII oocyte rate will be compared between the groups;To compare the number of embryos available for cryopreservation; verified by counting viable embryos that reached the appropriate stage in the laboratory; The mean number of embryos will be compared between the groups | — |
Countries
Brazil
Contacts
Public ContactRicardo Savaris
Hospital de Clínicas de Porto Alegre
Outcome results
None listed