Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
149
Subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference).
Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).
AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, Italy
Grade of use satisfaction reported by the patients
Patients will be asked how satisfied they are by the use of progesterone product that they receive in the luteal phase. Their satisfaction responses will be recorded on a scale of 1 to 3, with 1 being ''least satisfied'' and 3 being ''most satisfied'.
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Grade of quality of life impairment reported by the patients
Patients will be asked whether work life, social life, sexual life, and personal hygiene are perceived impaired by the progesterone treatment that they received. The answer for each item is "yes" or "no".
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Adverse effects (AEs)
Patients will be asked to report experienced AEs. The investigated AEs are sleepiness, dizziness, headache, bowel dysfunctions, breast pain/tension, weight changes, mood disorders, skin irritation, and vaginal discharge. The answer for each item is "yes" or "no".
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Progesterone administration route that the patients prefer
Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer.
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Implantation rate
Rate of positive human chorionic gonadotropin test
Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use
Clinically pregnancy rate
Rate of evolving pregnancy at ultrasound
Time frame: At 6 week from oocyte retrieval
live birth rate
Rate of baby delivered after 24 gestational weeks
Time frame: At nine months from oocyte retrieval
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