Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support in Gonadotropin Ovarian Stimulation for Intrauterine Insemination: a Pilot Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Subcutaneous progesterone; Drug: Vaginal progesterone

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 246
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Azienda Ospedaliera Pugliese-Ciaccio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Subcutaneous progesterone; 25 mg daily for 14 days; Other Names: Pleyris
Active Comparator: Vaginal Progesterone; 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; 90 mg daily for 14 days; Other Names: Crinone 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy	Number of patients with clinical pregnancy assessed by ultrasonography	8 weeks after IUI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	The side effects of Pleris (local reaction at the injection site) or Crinone treatment (vaginal irritation, inflammation, itching, leakage, and bleeding), as well as the systemic side effects (e.g., nausea, dizziness, breast pain) will be of particular interest and considered as secondary outcomes (tolerability).	Women will be followed for the duration of treatment, an expected average of 14 days

Collaborators and Investigators

• Sponsor: Roberta Venturella

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: December 7, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: Pleyris