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Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support

NCT02316626 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2016-11-22

No results posted yet for this study

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

Interventions

DRUG

Subcutaneous progesterone

25 mg daily for 14 days

DRUG

Vaginal progesterone

90 mg daily for 14 days

Sponsors & Collaborators

  • Roberta Venturella

    lead OTHER

Principal Investigators

  • Fulvio Zullo, MD,PhD · Magna Graecia University of Catanzaro

  • Roberta Venturella, MD · Magna Graecia University of Catanzaro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2016-01-31
Completion
2016-05-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316626 on ClinicalTrials.gov