Clinical trial NCT04306276: Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Official title: Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Endometriosis Ovary
IVF
Keywords: endometriosis
IVF
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 8 weeks
measure: Live birth rate after reaching 24 week's gestation
timeFrame: 24 weeks
Secondary outcomes:
measure: Total gonadotropin dose administered
timeFrame: During the procedure
measure: Number of mature oocytes collected
timeFrame: During the procedure
measure: Number of two-pronuclear (2PN) embryos
timeFrame: During the procedure
measure: Number of blastocysts.
timeFrame: During the procedure
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
affiliation: IRCCS Ospedale Policlinico San Martino
name: Fabio Barra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: