Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kocaeli Derince Education and Research Hospital | OTHER |
| Suleymaniye Birth And Women's Health Education And Research Hospital | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Progesterone resistance in endometriosis is a known fact. The progestin derivatives used in endometriosis cause decidualization and atrophy of ectopic foci. Moreover, they inhibit neo-angiogenesis, provide suppress expansile/destructive growth facilitated by matrix metalloproteinases, and implantation of ectopic foci. The effect of drugs containing the estrogen-progesterone combination is mainly based on the inhibition of ovulation, decidualization and atrophy of ectopic foci. In estrogen-progesterone mechanism, it is known that estrogen has a progesterone receptor-enhancing effect, which may make progesterone more potent. Based on this, the investigators hypothesized that estrogen added to progesterone could lead to a further reduction in endometrioma size by various mechanisms which probably include the increased progesterone sensitivity in endometriosis. In addition, the investigators hypothesized that this therapy can alleviate the destructive effect of endometriomas on the ovarian reserve.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group (patients with OMA) | Experimental | I) Untreated patients (n=142) II) Dienogest (n=142) III) Dienogest/Estradiol valerate+Dienogest (n=142) |
|
| Control Group(patients without OMA) | Sham Comparator | I) Untreated patients (n=142) II) Dienogest/Estradiol valerate+Dienogest (n=142) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol valerate/dienogest | Drug | The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian reserve | The investigators evaluate serum anti-Müllerian hormone (AMH) level(ng/mL) using commercial elisa kits and antral follicle count (number) using ultrasonography. The patients with higher ovarian reserve represent a better outcome. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrioma Size | The investigators evaluate endometrioma size (centimeter) using ultrasonography. | up to 24 months |
| Pain Score | Vas score (minimum score:0 and maximum score:10). The patients with lower pain scores represent a better outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tolga Karacan, M.D | Contact | 05303638765 | tolgakaracan84@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Engin Oral, Prof.Dr. M.D | Istanbul University Cerrahpasa Medical Faculty | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tolga Karacan | Recruiting | Istanbul | Bagcilar | 34100 | Turkey (Türkiye) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C454300 | estradiol valerate-dienogest |
| C023635 | dienogest |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| up to 24 months |
| D000091662 | Genital Diseases |