Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Subcutaneous progesterone; Drug: Vaginal progesterone

• Registration Number: NCT02316626
• Lead Sponsor: Roberta Venturella

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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-07
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-15
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 246

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subcutaneous progesterone	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.
Vaginal Progesterone	Vaginal progesterone	Luteal phase support cycles will involve once-daily administration of 90 mg vaginal gel from the day after insemination for 14 days.

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	8 weeks after IUI	Number of patients with clinical pregnancy assessed by ultrasonography

Secondary Outcome Measures

Name	Time	Method
side effects	Women will be followed for the duration of treatment, an expected average of 14 days	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).

Trial Locations

Locations (1)

Azienda Ospedaliera Pugliese-Ciaccio; 🇮🇹 Catanzaro, Italy