Overview

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

Status:
Terminated
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Andros Day Surgery Clinic
Treatments:
Cetrorelix
Progesterone
Criteria
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)