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

In Vitro Fertilization Clinical Trial

— PROPER-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734770
• Other study ID #: PROPER-1
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2022
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: July 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• In Vitro Fertilization
• Luteal Phase Support
• Progesterone

Intervention

Drug:
• Subcutaneous Progesterone
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).
• Vaginal progesterone
Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Implantation rate	Rate of positive human chorionic gonadotropin test	At the human chorionic gonadotropin test performed after 14 days of progesterone use
Secondary	Clinically pregnancy rate	Rate of evolving pregnancy at ultrasound	At 6 week from oocyte retrieval
Secondary	live birth rate	Rate of baby delivered after 24 gestational weeks	At nine months from oocyte retrieval