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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04306276
• Other study ID #: DIENIVF-ENDO
• Status: Completed
• Start date: January 1, 2020
• Est. completion date: March 1, 2020

Study information

• Verified date: March 2020
• Source: Ospedale Policlinico San Martino
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Endometriosis
• Endometriosis Ovary
• IVF

Intervention

Drug:
• Dienogest 2 MG
Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Policlinico San Martino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		8 weeks
Primary	Live birth rate after reaching 24 week's gestation		24 weeks
Secondary	Total gonadotropin dose administered		During the procedure
Secondary	Number of mature oocytes collected		During the procedure
Secondary	Number of two-pronuclear (2PN) embryos		During the procedure
Secondary	Number of blastocysts.		During the procedure