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Completed

NCT Number: NCT03734770

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

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.

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Key information

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Verona, 37125, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

vaginal progesterone

Drug

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

Primary outcomes

  1. 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'.

  2. 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".

  3. 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

  1. Progesterone administration route that the patients prefer

    Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use

    Patients of subcutaneous progesterone arm and who had previously used vaginal progesterone will be asked which administration route they prefer.

  2. Implantation rate

    Time frame: At the human chorionic gonadotropin test performed after 14 days of progesterone use

    Rate of positive human chorionic gonadotropin test

  3. Clinically pregnancy rate

    Time frame: At 6 week from oocyte retrieval

    Rate of evolving pregnancy at ultrasound

  4. live birth rate

    Time frame: At nine months from oocyte retrieval

    Rate of baby delivered after 24 gestational weeks

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

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

Acronym: PROPER-1

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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