Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316626
• Other study ID #: Pleyris
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2014
• Last updated: November 21, 2016
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2016
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: May 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Subcutaneous progesterone
25 mg daily for 14 days
• Vaginal progesterone
90 mg daily for 14 days

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Pugliese-Ciaccio	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
Roberta Venturella

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy	Number of patients with clinical pregnancy assessed by ultrasonography	8 weeks after IUI	No
Secondary	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	Yes