NCT04306276

Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

It is generally assumed that the major causes of in vitro fertilization (IVF) failure in women with endometriosis are diminished ovarian reserve, impaired endometrial receptivity and low quality of embryos. The use of prolonged courses of hormone therapy may play an important role in the strategy of overcoming endometriosis-related infertility. The aim of this study was to evaluate the use of dienogest (DNG) before an IVF cycle in women with endometriosis undergone a previous IVF failed cycle

Detailed description

The primary outcomes of the study are clinical pregnancy rate and live birth rate after reaching 24 week's gestation. Secondary outcomes of the study are: changes in the diameter and volume of the largest endometrioma, total gonadotropin dose administered, number of mature oocytes collected, number of two-pronuclear (2PN) embryos, number of blastocysts.

Conditions

• Endometriosis
• Endometriosis Ovary
• IVF

Interventions

Type	Name	Description
DRUG	Dienogest 2 MG	Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2020-03-12
• Last updated: 2020-03-12

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study