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

Completed

• Conditions: Endometriosis; Endometriosis Ovary; IVF
• Interventions: Drug: Dienogest 2 MG

• Registration Number: NCT04306276
• Lead Sponsor: Ospedale Policlinico San Martino

Brief 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.

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2020-03
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Study First Submitted: 2020-03-08
• Study First Submitted QC: 2020-03-10
• Last Update Submitted: 2020-03-10
• Study First Posted: 2020-03-12
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• diagnosis of endometriosis at magnetic resonance imaging or transvaginal ultrasonography;
• one failed previous IVF cycle (including failure of frozen embryo transfer);
• basal FSH < 14.0 IU/L;
• antimullerian hormone (AMH) blood level >= 0.5 g/mL;
• normal thyroid-stimulating hormone and prolactin.

Exclusion Criteria

• history of surgery for endometriosis;
• history of uterine or adnexal surgery;
• use of hormonal therapies for the treatment of endometriosis related pain within 6 months before IVF;
• adenomyosis (magnetic resonance imaging or transvaginal ultrasonography);
• hydrosalpinx;
• submucosal fibroids;
• body mass index (BMI) ≥ 30 kg/m2;
• severe male factor infertility (< 5 million total motile sperm count).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients pretreated with DNG	Dienogest 2 MG	Patients having received a three-month treatment with DNG before undergoing IVF

Primary Outcome Measures

Name	Time	Method
Live birth rate after reaching 24 week's gestation	24 weeks
Clinical pregnancy rate	8 weeks

Secondary Outcome Measures

Name	Time	Method
Number of blastocysts.	During the procedure
Number of mature oocytes collected	During the procedure
Total gonadotropin dose administered	During the procedure
Number of two-pronuclear (2PN) embryos	During the procedure

Trial Locations

Locations (1)

IRCCS Ospedale Policlinico San Martino; 🇮🇹 Genoa, Italy