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

NCT03181685 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-10

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Progesterone 25 MG subcutaneous

A single subcutaneous administration per day from the day of oocyte retrieval

DRUG

Micronized progesterone 200 MG

3 vaginal administrations per day from the day of oocyte retrieval

DRUG

recombinant FSH

Controlled ovarian stimulation (COS)

DRUG

Cetrorelix Acetate

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Sponsors & Collaborators

  • Andros Day Surgery Clinic

    lead OTHER

Principal Investigators

  • Adolfo Allegra, MD · Andros Day Surgery Clinic

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-20
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181685 on ClinicalTrials.gov