Current partner codePEPTIDESDE
NCT03181685·Phase 4·INTERVENTIONAL

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

Status

Terminated

Phase

Phase 4

Enrollment

60

Locations

1

Results

Not posted

Publications

3

Study summary

What the protocol is testing.

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).

Full 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

Treatment arms and agents.

DRUG

Progesterone 25 MG subcutaneous

A single subcutaneous administration per day from the day of oocyte retrieval

DRUG

Micronized progesterone 200 MG

3 vaginal administrations per day from the day of oocyte retrieval

DRUG

recombinant FSH

Controlled ovarian stimulation (COS)

DRUG

Cetrorelix Acetate

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Timeline

From registration to results.

  1. First posted

    Jun 9, 2017

  2. Study start

    Dec 20, 2016

  3. Primary completion

    Dec 2019

  4. Study completion

    Dec 2019

  5. Results posted

    Not reported

  6. Registry updated

    Jan 10, 2020

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
44 Years
Sex
FEMALE
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)

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

ANDROS Day Surgery Clinic, Reproductive Medicine Unit

Palermo, Italy

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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