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Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

NCT ID: NCT02316626

Last Updated: 2016-11-22

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-05-31

Brief Summary

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It is well known that implantation of the developing blastocyst occurs during the luteal phase of the menstrual cycle when the endometrium is under the direct influence of Progesterone (P).Several prospective randomized controlled trials have evaluated the benefits of luteal phase P support in ovulation induction cycles and a recent review and meta-analysis demonstrated that it may be of benefit to patients undergoing ovulation induction with gonadotropins in intrauterine insemination (IUI) cycles. Until now, injectable P was offered only in an oil-base solution owing to the insoluble properties of the molecule, which made the IM route mandatory. A recent publication, however, demonstrated the efficacy of a new P formulation that could be a game changer. The aim of the present pilot trial will be to compare the efficacy and tolerability of 25 mg/d of the new SC P with 90 mg/d of vaginal gel P for luteal phase support (LPS) in COH and IUI cycles.

Detailed Description

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The present randomized study will be conducted to compare the safety, effectiveness and tolerability of SC P (Pleyris; IBSA Institut Biochimique SA) with vaginal P gel (Crinone; Merck Serono) for LPS in COH/IUI cycles. The study will be conducted, recorded and reported in compliance with the principles of Good Clinical Practice (GCP) guidelines at the Department of Obstetrics and Gynecology of Magna Graecia University of Catanzaro.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subcutaneous progesterone

Luteal phase support cycles will involve once-daily administration of 25 mg of SC P from the day after insemination for 14 days.

Group Type EXPERIMENTAL

Subcutaneous progesterone

Intervention Type DRUG

25 mg daily for 14 days

Vaginal Progesterone

Luteal phase support cycles will involve once-daily administration of 90 mg vaginal gel from the day after insemination for 14 days.

Group Type ACTIVE_COMPARATOR

Vaginal progesterone

Intervention Type DRUG

90 mg daily for 14 days

Interventions

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Subcutaneous progesterone

25 mg daily for 14 days

Intervention Type DRUG

Vaginal progesterone

90 mg daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Pleyris Crinone 8

Eligibility Criteria

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Inclusion Criteria

\<38 years of age with either primary or secondary infertility for at least 1 years; body mass index between 19 and 30 kg/m2; Day 2 serum FSH \<15 IU/ml; normal serum prolactin level; normal uterine cavity on hysterosalpingography or hysteroscopy.-

Exclusion Criteria

female partners with previous ovarian surgery, one ovary, polycystic ovaries on ultrasound examination, other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders, hyperprolactinemia, hypogonadotropic hypogonadism), diminished ovarian reserve (basal FSH level \>15 IU/mL), or age of \>38 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Roberta Venturella

OTHER

Sponsor Role lead

Responsible Party

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Roberta Venturella

MD, PhD Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fulvio Zullo, MD,PhD

Role: STUDY_DIRECTOR

Magna Graecia University of Catanzaro

Roberta Venturella, MD

Role: PRINCIPAL_INVESTIGATOR

Magna Graecia University of Catanzaro

Locations

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Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, Italy

Site Status

Countries

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Italy

Other Identifiers

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Pleyris

Identifier Type: -

Identifier Source: org_study_id