DRUG
Progesterone 25 MG subcutaneous
A single subcutaneous administration per day from the day of oocyte retrieval
Status
Terminated
Phase
Phase 4
Enrollment
60
Locations
1
Results
Not posted
Publications
3
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).
Each participant will receive both treatments. During the first IVF/ICSI cycle, the luteal phase will be supplemented with subcutaneous progesterone (S) or vaginal progesterone (V). At the end of the cycle (on the day of beta-hCG), a survey for determining the level of satisfaction will be administered and filled in by the patient during the waiting time and always before the knowledge of the result. This practical organization allows the elimination of emotional biases correlated with the outcome. In case of a negative beta-hCG, the patient will be scheduled for a second IVF/ICSI cycle after a washout (W) period (between 2 and 6 months). In the second cycle, the patient will undergo, during the luteal phase, the opposite treatment (V or S). Also in this case, the survey for evaluating the level of satisfaction will be administered on the day of beta-hCG, with the same modalities of the first cycle. The domains of the surveys are focused on facility of the administration, comfort, level of complaint, side effects, overall level of satisfaction. The sequence S-V or V-S will be randomly assigned (random assignment) with the concealment of the allocation. In case of a negative beta-hCG also in the second cycle, a post-hoc comparison between the two treatments will be carried out through a Semantic Differential Scale, in the "follow-up" phase.
Interventions
DRUG
A single subcutaneous administration per day from the day of oocyte retrieval
DRUG
3 vaginal administrations per day from the day of oocyte retrieval
DRUG
Controlled ovarian stimulation (COS)
DRUG
Inhibition of Luteinizing Hormone (LH) premature surge during COS
Timeline
First posted
Jun 9, 2017
Study start
Dec 20, 2016
Primary completion
Dec 2019
Study completion
Dec 2019
Results posted
Not reported
Registry updated
Jan 10, 2020
Outcomes
Surveys for testing the satisfaction
Time frame · Single administration at the end of each treatment cycle (an average of 28 days)
Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response
Semantic Differential Scale
Time frame · Single administration at the end of two treatment cycles (an average of 130 days)
Patient's preference of treatment measured on a 7-point likert scale
Eligibility
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)
Study locations
Italy. Showing up to 24 locations stored in the fast local snapshot.
ANDROS Day Surgery Clinic, Reproductive Medicine Unit
Palermo, Italy
Publications
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