Status:
COMPLETED
Pretreatment With Dienogest in Women With Endometriosis Undergoing in Vitro-fertilization After a Previous Failed Cycle
Lead Sponsor:
Ospedale Policlinico San Martino
Conditions:
Endometriosis
Endometriosis Ovary
Eligibility:
FEMALE
18-40 years
Brief Summary
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 em...
Detailed Description
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 la...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04306276
Start Date
January 1 2020
End Date
March 1 2020
Last Update
March 12 2020
Active Locations (1)
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1
IRCCS Ospedale Policlinico San Martino
Genoa, Italy, 16132