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

Study Overview
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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

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.

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

Conditions
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Endometriosis, Endometriosis Ovary, IVF

Intervention / Treatment
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* Drug: Dienogest 2 MG


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing direct IVF<br>Patients directly undergo IVF without receiving previous hormonal treatment | |
| Patients pretreated with DNG<br>Patients having received a three-month treatment with DNG before undergoing IVF | Drug: Dienogest 2 MG<br>* Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | 8 weeks | 
| Live birth rate after reaching 24 week's gestation |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, endometriosis