Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.
Overview
- Phase
- Not Applicable
- Intervention
- Subcutaneous Progesterone
- Conditions
- Progesterone
- Sponsor
- Universita di Verona
- Enrollment
- 149
- Locations
- 1
- Primary Endpoint
- Grade of use satisfaction reported by the patients
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Simone Garzon
Principal Investigator
Universita di Verona
Eligibility Criteria
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
Arms & Interventions
Subcutaneous progesterone
After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive 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) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.
Intervention: Subcutaneous Progesterone
Vaginal progesterone
After standard stimulating protocol for IVF, beginning on the day of oocyte retrieval allocated patients receive micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours) for at least 8 gestational weeks or confirmation of a negative pregnancy test performed 14 days after oocyte retrieval.
Intervention: Vaginal progesterone
Outcomes
Primary Outcomes
Grade of use satisfaction reported by the patients
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Progesterone administration route that the patients prefer(At the human chorionic gonadotropin test performed after 14 days of progesterone use)
- Implantation rate(At the human chorionic gonadotropin test performed after 14 days of progesterone use)
- Clinically pregnancy rate(At 6 week from oocyte retrieval)
- live birth rate(At nine months from oocyte retrieval)