Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support

Study Overview
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Brief Summary
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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.

Official Title
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Patient's Preferences About Subcutaneous or Vaginal Progesterone Administration for Luteal Phase Support: Prospective Randomized Trial.

Conditions
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Progesterone, Luteal Phase Support, In Vitro Fertilization

Intervention / Treatment
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* Drug: Subcutaneous Progesterone
* Drug: Vaginal progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subcutaneous progesterone<br>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. | Drug: Subcutaneous Progesterone<br>* 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).<br>|
| Active Comparator: Vaginal progesterone<br>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. | Drug: Vaginal progesterone<br>* Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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'. | 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. | 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. | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 
| Implantation rate | Rate of positive human chorionic gonadotropin test | At the human chorionic gonadotropin test performed after 14 days of progesterone use | 
| Clinically pregnancy rate | Rate of evolving pregnancy at ultrasound | At 6 week from oocyte retrieval | 
| live birth rate | Rate of baby delivered after 24 gestational weeks | At nine months from oocyte retrieval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progesterone, subcutaneous, vaginal, luteal phase support, in vitro fertilization