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

Phase 4

Terminated

• Conditions: Infertility; In Vitro Fertilization
• Interventions: Drug: Progesterone 25 MG subcutaneous; Drug: Micronized progesterone 200 MG; Drug: recombinant FSH; Drug: Cetrorelix Acetate

• Registration Number: NCT03181685
• Lead Sponsor: Andros Day Surgery Clinic

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.

Study Timeline

• Study Start: 2016-12-20
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment S (Subcutaneous)	Progesterone 25 MG subcutaneous	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.
Treatment S (Subcutaneous)	recombinant FSH	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.
Treatment S (Subcutaneous)	Cetrorelix Acetate	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.
Treatment V (Vaginal)	Micronized progesterone 200 MG	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.
Treatment V (Vaginal)	recombinant FSH	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.
Treatment V (Vaginal)	Cetrorelix Acetate	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

ANDROS Day Surgery Clinic, Reproductive Medicine Unit; 🇮🇹 Palermo, Italy