NCT03701490

Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)

A Proof of Concept, Randomized, Controlled Clinical Trial to Assess the Efficacy of Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone (Progeffik) for Endometrial Preparation in Women Undergoing Frozen Embryo Transfer(FET) Cycles

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: IBSA Institut Biochimique SA · Industry
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Progesterone subcutaneous	25 mg/twice a day.
DRUG	Progesterone Vaginal Product	200 mg three times a day.

Timeline

• Start date: 2019-03-12
• Primary completion: 2022-09-28
• Completion: 2022-12-03
• First posted: 2018-10-10
• Last updated: 2024-11-22

Locations

3 sites across 1 country: Spain