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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-20

Study Completion Date

2019-12-31

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).

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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.

Conditions

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Infertility In Vitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment S (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.

Group Type ACTIVE_COMPARATOR

Progesterone 25 MG subcutaneous

Intervention Type DRUG

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

recombinant FSH

Intervention Type DRUG

Controlled ovarian stimulation (COS)

Cetrorelix Acetate

Intervention Type DRUG

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Treatment V (Vaginal)

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.

Group Type ACTIVE_COMPARATOR

Micronized progesterone 200 MG

Intervention Type DRUG

3 vaginal administrations per day from the day of oocyte retrieval

recombinant FSH

Intervention Type DRUG

Controlled ovarian stimulation (COS)

Cetrorelix Acetate

Intervention Type DRUG

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Interventions

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Progesterone 25 MG subcutaneous

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

Intervention Type DRUG

Micronized progesterone 200 MG

3 vaginal administrations per day from the day of oocyte retrieval

Intervention Type DRUG

recombinant FSH

Controlled ovarian stimulation (COS)

Intervention Type DRUG

Cetrorelix Acetate

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Intervention Type DRUG

Other Intervention Names

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Pleyris Prometrium Gonal-f Cetrotide

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No