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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-03-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Endometriosis Endometriosis Ovary IVF

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients undergoing direct IVF

Patients directly undergo IVF without receiving previous hormonal treatment

No interventions assigned to this group

Patients pretreated with DNG

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

Dienogest 2 MG

Intervention Type DRUG

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

Interventions

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Dienogest 2 MG

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

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No