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Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

Information source: University Magna Graecia
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Subcutaneous progesterone (Drug); Vaginal progesterone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Magna Graecia

Official(s) and/or principal investigator(s):
Fulvio Zullo, MD,PhD, Principal Investigator, Affiliation: Magna Graecia University of Catanzaro

Overall contact:
Fulvio Zullo, MD,PhD, Phone: 00390961883234, Email: zullo@unicz.it

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.

Clinical Details

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

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

Primary outcome: Clinical pregnancy

Secondary outcome: side effects

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.

Eligibility

Minimum age: 18 Years. Maximum age: 38 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Fulvio Zullo, MD,PhD, Phone: 00390961883234, Email: zullo@unicz.it

Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro 88100, Italy; Recruiting
Fulvio Zullo, Phone: 00390961883234, Email: zullo@unicz.it
Additional Information

Starting date: December 2014
Last updated: December 10, 2014

Page last updated: August 23, 2015

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