Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

NCT02316626 | Completed Phase 4 DMC

• 1 other identifier: Pleyris
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  Number of patients with clinical pregnancy assessed by ultrasonography

  8 weeks after IUI

Secondary Outcomes (1)

• side effects

  Women will be followed for the duration of treatment, an expected average of 14 days

Study Arms (2)

Subcutaneous progesterone

EXPERIMENTAL

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

Drug: Subcutaneous progesterone

Vaginal Progesterone

ACTIVE COMPARATOR

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

Drug: Vaginal progesterone

Interventions

Subcutaneous progesterone DRUG

25 mg daily for 14 days

Also known as: Pleyris

Subcutaneous progesterone

Vaginal progesterone DRUG

90 mg daily for 14 days

Also known as: Crinone 8

Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \<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.-

You may not qualify if:

• 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

Sponsors & Collaborators

• Roberta Venturella: lead

Study Sites (1)

Azienda Ospedaliera Pugliese-Ciaccio

Catanzaro, Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Fulvio Zullo, MD,PhD

  Magna Graecia University of Catanzaro

  STUDY DIRECTOR

• Roberta Venturella, MD

  Magna Graecia University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD Student

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Locations

IT (1)