NCT02316626

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

Completed Phase 4 Last updated 21 November 2016

What this trial tests

Phase 4 trial testing Subcutaneous progesterone in Infertility in 246 participants. Completed in 1 May 2016.

Timeline

1 December 2014

Primary endpoint
1 January 2016

1 May 2016

Quick facts

Lead sponsor	Roberta Venturella
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	246
Start date	1 December 2014
Primary completion	1 January 2016
Estimated completion	1 May 2016
Sites	1 location across Italy

Drugs / interventions tested

• Subcutaneous progesterone — full drug profile →
• Vaginal progesterone — full drug profile →

Conditions studied

• Infertility — all drugs for Infertility →

Sponsor

Roberta Venturella

Who can join

Adults 18 to 38, female only, with Infertility. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Clinical pregnancy
  Time frame: 8 weeks after IUI
  Number of patients with clinical pregnancy assessed by ultrasonography

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Luteal phase support for assisted reproduction cycles.
   van der Linden M, Buckingham K, Farquhar C, Kremer JA, et al · · 2015 · cited 170× · PMID 26148507 · DOI 10.1002/14651858.cd009154.pub3