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Trial · Interventional

TerminatedPhase 4Registry data

Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles

NCTNCT03181685 (opens ClinicalTrials.gov in a new tab)Other idAndros Day Surgery Clinic
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
Andros Day Surgery Clinic · Other
Design
Randomized · Single masking
Countries
1 country

Italy

Start
20 Dec 2016
Primary completion
Dec 2019
Completion
Dec 2019
First posted
9 Jun 2017
Last update posted
10 Jan 2020
Conditions
Infertility · In Vitro Fertilization

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 4

    Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles

    NCT03181685

    20 Dec 2016 to Dec 2019

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one. The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation, Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg (3 vaginal administrations per day).

Interventions

  • Progesterone 25 MG subcutaneousDrug
  • Micronized progesterone 200 MGDrug
  • recombinant FSHDrug
  • Cetrorelix AcetateDrug

Arms2

  • Active comparator

    Treatment S (Subcutaneous)

    Progesterone 25 mg subcutaneous (a single administration per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate.

  • Active comparator

    Treatment V (Vaginal)

    Micronized progesterone 200 mg (3 vaginal administrations per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Surveys for testing the satisfaction

    Time frame · Single administration at the end of each treatment cycle (an average of 28 days)

    Registry description

    Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response

Secondary outcomes(1)

  1. Semantic Differential Scale

    Time frame · Single administration at the end of two treatment cycles (an average of 130 days)

    Registry description

    Patient's preference of treatment measured on a 7-point likert scale

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 44 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: first IVF/ICSI attempt (at the enrolment), regular menstrual cycles (25-33 days), controlled ovarian stimulation performed with Gonadotropin Releasing Hormone (GnRH) antagonists and gonadotrophins (recombinant FSH) Exclusion Criteria: systemic diseases, chronic medical therapies, pregnancy in one of the IVF/ICSI cycles, embryo "freeze all" strategy in one of the IVF/ICSI cycles for preventing Ovarian Hyperstimulation Syndrome (OHSS)

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