Women with endometriosis who have been diagnosed with Stages III -IV according to rASRM criteria
Conditions
Interventions
Trade Name: Enantone-Gyn Monats-Depot
Product Name: Enantone-Gyn Monats-Depot
Pharmaceutical Form: Injection*
CAS Number: 53714-56-0
Current Sponsor code: Enantone
Other descriptive name: Leuporelinac
Sponsors
Dr. Peter Sydow
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: women of age 18-40 with diagnosis of endometriosis stages III-IV according to rASRM criteria who had surgery during the last 3 month before beeing recruites to the study FSH=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: pregnancy and lactation all contraindications against tested medication all possible interaction (e.g. allergies) with tested medication participation in other clinical trial parallel or 8 weeks prior to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective of the trial is to find out, whether women with Stage III-IV rASRM endometriosis benefit from the therapy with leuporelinacetat prior to IVF - therapy. Primary endpoint of the study is the pregnancy rate in the 3 study groups. ;Secondary Objective: Number of follicles on day 2-3 17-beta-Estradiol [pg/ml] FSH on day 2-3 days until hCG is given thickness of endometrial layer when hCG is given [mm] number of pre-ovulatory follicles bigger than 14 mm when hCG is given 17-beta-Estradiol [pg/ml] when hCG is given 17-beta-Estradiol / follicle > 14 mm [pg/ml] oocyte retrieval possible[ja/nein] number of oocytes quality of oocytes (maturity) (Ordinalscale of 4 qualities) fertilisation rate [ordinalscale with 4 degrees] number of kryoconserved Embryos quality of embryos– grade of blastomeres [ordinalscale with 3 degrees] quality of embryos – number of fragments [ordinalscale with 4 degrees] quality of embryos – cleavage rate 48 h after Insemination [ordinalscale with 4 degrees] embryotransfer [yes/no] embryotransfers [0,1,2,3] multiple pregnancies [2,3] number of abortions before 12. week o gestation rate of ectopic pregnancies birth – at term [yes/no] elective caesarian section [yes/no] number of malformations ;Primary end point(s): pregnancy rate | — |
Countries
Germany
Outcome results
None listed