Infertility, In Vitro Fertilization
Conditions
Keywords
Progesterone supplementation, IVF, Preference expressed by the patient
Brief 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).
Detailed description
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
DRUGProgesterone 25 MG subcutaneous
A single subcutaneous administration per day from the day of oocyte retrieval
3 vaginal administrations per day from the day of oocyte retrieval
DRUGrecombinant FSH
Controlled ovarian stimulation (COS)
Inhibition of Luteinizing Hormone (LH) premature surge during COS
Sponsors
Andros Day Surgery Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Intervention model description
This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surveys for testing the satisfaction | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semantic Differential Scale | 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 |
Countries
Italy
Outcome results
None listed