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

Ospedale Policlinico San Martino

Status: Completed

Conditions: IVF; Endometriosis; Endometriosis Ovary

Treatments: Drug: Dienogest 2 MG

Study type: Observational

Funder types: Other

Identifiers

NCT04306276

DIENIVF-ENDO

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

140 participants in 2 patient groups

Patients undergoing direct IVF

Description:

Patients directly undergo IVF without receiving previous hormonal treatment

Patients pretreated with DNG

Description:

Patients having received a three-month treatment with DNG before undergoing IVF

Treatment:

Drug: Dienogest 2 MG