In Vitro Fertilization, Luteal Phase Support, Progesterone
Conditions
Keywords
progesterone, subcutaneous, vaginal, luteal phase support, in vitro fertilization
Brief summary
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.
Interventions
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).
DRUGVaginal progesterone
Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective randomized trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* Infertile women candidate to undergo fresh IVF cycles
Exclusion criteria
* day-3 follicle-stimulating hormone (FSH) levels over 15 IU/L * clinically relevant systemic disease (e.g., uncontrolled thyroid and adrenal dysfunction, an organic intracranial lesion such as a pituitary tumor, insulin-dependent diabetes mellitus, cancers) * hypersensitivity to any of the study drugs * contraindications to use the study drugs * surgical or medical condition that would interfere with absorption, distribution, metabolism, or excretion of the study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade of use satisfaction reported by the patients | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 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'. |
| Grade of quality of life impairment reported by the patients | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 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. |
| Adverse effects (AEs) | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progesterone administration route that the patients prefer | At the human chorionic gonadotropin test performed after 14 days of progesterone use | Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer. |
| live birth rate | At nine months from oocyte retrieval | Rate of baby delivered after 24 gestational weeks |
| Implantation rate | At the human chorionic gonadotropin test performed after 14 days of progesterone use | Rate of positive human chorionic gonadotropin test |
| Clinically pregnancy rate | At 6 week from oocyte retrieval | Rate of evolving pregnancy at ultrasound |
Countries
Italy
Outcome results
None listed