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With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRH analog alone | Active Comparator | control group treated with GnRH analog alone |
|
| Aromatase inhibitor plus GnRH analog | Experimental | experimental group treated with aromatase inhibitor plus GnRH analog |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH analog (11.25mg Leuprolide acetate) | Drug | 11.25 Leuprolide acetate only one administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| pregnancy after embryo transfer | after treatment patients undergo embryo transfer of a cryopreservad blastocyst | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| uterine volume reduction | differences in uterine volume pre and post treatment evaluated by ultrasound | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARCO SBRACIA, MD | CERM-HUNGARIA | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spitali Amerikan | Tirana | Albania | ||||
| Nadezda Women's Health Hospital |
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Randomized controlled trial in two arms study (150 each one)
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Patients will take similar kind medications by an indipendent person
| Aromatase inhibitor and GnRH analog | Drug | 1mg/day of Anastrazole for 3 months |
|
|
| Aromatase and GnRH analog (11.25mg Leuprolide acetate) | Drug | Leuprolide acetate 11.25mg only one |
|
|
| Sofia |
| Bulgaria |
| Cerm-Hungaria | Rome | 00153 | Italy |
| ID | Term |
|---|---|
| D062788 | Adenomyosis |
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D016729 | Leuprolide |
| D035061 | Control Groups |
| D047072 | Aromatase Inhibitors |
| D001141 | Aromatase |
| ID | Term |
|---|---|
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D000072496 | Cytochrome P450 Family 19 |
| D003577 | Cytochrome P-450 Enzyme System |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D013250 | Steroid Hydroxylases |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D006420 | Hemeproteins |
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