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

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.

Conditions

• Progesterone
• Luteal Phase Support
• In Vitro Fertilization

Interventions

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).

DRUG

Vaginal progesterone

Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).

Sponsors & Collaborators

• Universita di Verona

  lead OTHER

Principal Investigators

• Simone Garzon, M.D. · Universita di Verona

• Rossana Di Paola, M.D. · Universita di Verona

• Antonio Simone Laganà · Università degli Studi dell'Insubria

• Francesca Parissone, M.D. · Universita di Verona

• Stefano Zaffagnini, M.D. · AOUI Verona

• Massimo Franchi, M.D. · Universita di Verona

• Ricciarda Raffaelli, M.D. · Universita di Verona

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2019-03-01

Completion

2019-07-01

Countries

• Italy

Study Locations