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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04306276

Enrollment

140

Registered

2020-03-12

Start date

2020-01-01

Completion date

2020-03-01

Last updated

2020-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis, Endometriosis Ovary, IVF

Keywords

endometriosis, IVF

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.

Interventions

DRUGDienogest 2 MG

Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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).

Design outcomes

Primary

Measure	Time frame
Clinical pregnancy rate	8 weeks
Live birth rate after reaching 24 week's gestation	24 weeks

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026