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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Subcutaneous Versus Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles: Which is the Preference Expressed by the Patients?

Conditions
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Infertility, In Vitro Fertilization

Intervention / Treatment
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* Drug: Progesterone 25 MG subcutaneous
* Drug: Micronized progesterone 200 MG
* Drug: recombinant FSH
* Drug: Cetrorelix Acetate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment S (Subcutaneous)<br>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. | Drug: Progesterone 25 MG subcutaneous<br>* A single subcutaneous administration per day from the day of oocyte retrieval<br>* Other names: Pleyris;Drug: recombinant FSH<br>* Controlled ovarian stimulation (COS)<br>* Other names: Gonal-f;Drug: Cetrorelix Acetate<br>* Inhibition of Luteinizing Hormone (LH) premature surge during COS<br>* Other names: Cetrotide;|
| Active Comparator: Treatment V (Vaginal)<br>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. | Drug: Micronized progesterone 200 MG<br>* 3 vaginal administrations per day from the day of oocyte retrieval<br>* Other names: Prometrium;Drug: recombinant FSH<br>* Controlled ovarian stimulation (COS)<br>* Other names: Gonal-f;Drug: Cetrorelix Acetate<br>* Inhibition of Luteinizing Hormone (LH) premature surge during COS<br>* Other names: Cetrotide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surveys for testing the satisfaction | Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response | Single administration at the end of each treatment cycle (an average of 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semantic Differential Scale | Patient's preference of treatment measured on a 7-point likert scale | Single administration at the end of two treatment cycles (an average of 130 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, Progesterone supplementation, Preference expressed by the patient