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

NCT03734770 | Completed

• 1 other identifier: PROPER-1
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Progesterone; Luteal Phase Support; In Vitro Fertilization

Keywords

progesterone; subcutaneous; vaginal; luteal phase support; in vitro fertilization

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (2)

Subcutaneous progesterone

ACTIVE COMPARATOR

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

Vaginal progesterone

ACTIVE COMPARATOR

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

Interventions

Subcutaneous Progesterone DRUG

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).

Subcutaneous progesterone

Vaginal progesterone DRUG

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

Vaginal progesterone

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile women candidate to undergo fresh IVF cycles

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, 37125, Italy

Location

Study Officials

• Simone Garzon, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Rossana Di Paola, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Antonio Simone Laganà

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

• Francesca Parissone, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Stefano Zaffagnini, M.D.

  AOUI Verona

  STUDY DIRECTOR

• Massimo Franchi, M.D.

  Universita di Verona

  STUDY DIRECTOR

• Ricciarda Raffaelli, M.D.

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective randomized trial

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 8, 2018
• Study Start: January 1, 2019
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2019
• Last Updated: May 18, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)