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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing direct IVF | Patients directly undergo IVF without receiving previous hormonal treatment | ||
| Patients pretreated with DNG | Patients having received a three-month treatment with DNG before undergoing IVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dienogest 2 MG | Drug | Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | 8 weeks | |
| Live birth rate after reaching 24 week's gestation | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with endometriosis who previously failed one IVF cycle and all resultant frozen embryo transfer
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| Name | Affiliation | Role |
|---|---|---|
| Fabio Barra, MD, PhD | IRCCS Ospedale Policlinico San Martino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Policlinico San Martino | Genoa | 16132 | Italy |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C023635 | dienogest |
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| During the procedure |
| Number of blastocysts. | During the procedure |
| D000091662 | Genital Diseases |