Infertilty in women with adenomyosis.
Conditions
Interventions
Trade Name: Decapeptyl
Product Name: Decapeptyl
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: Vivelledot
Sponsors
University Hospital Toulouse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) suspected adenomyosis on high quality TV US or focal or diffuse adenomyosis defined as a thickening of the JZ to more than 12mm on previous MRI (18 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) absence of adenomyosis (defined as a thickening of the JZ to more than 12mm) on pelvic MRI 2) other potential causes of implantation failure: leiomyoma, endometrial polyp, not removed hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome 3) medical contraindication to study treatments (GnRH agonist and add-back therapy) 4)history of previous prolonged GnRH agonist treatment (> 3 months) within 6 months prior study treatment start 5) women taking prohibited concomitant treatments and not able to stop them for the study period 6) medical contraindication to assisted reproductive technique and/or pregnancy including: uncontrolled type I and II diabetes; undiagnosed liver disease or dysfunction; renal insufficiency; history of deep venous thrombosis, pulmonary embolism or cerebrovascular accident; uncontrolled hypertension; known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, ovarian carcinoma or breast carcinoma; undiagnosed vaginal bleeding; genetic abnormalities 7) positive plasma viral load for HIV, HCV or HBV for one (or both) in the couple during the year before inclusion 8) participation in another research study including an exclusion period which has not expired at the time of screening 9) patients subject to a judicial safeguard order, guardianship or trusteeship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of ultra-long protocol versus long protocol on the live birth rate after first or second IVF/ICSI attempt in infertile women with adenomyosis.; Secondary Objective: To compare ultra-long and long protocols efficacy after first or second IVF/ICSI in terms of: -uterine volume reduction following pituitary down-regulation -low responders rate -biochemical pregnancy -implantation rate -clinical pregnancy -clinical pregnancy with fetal heart beat -ongoing pregnancy at the end of first trimester -first trimester miscarriage To assess treatment safety and tolerability in both arms in terms of specific menopause-like symptoms at the end of down-regulation treatment, To assess Adverse Events occurrence during down-regulation treatment, during IVF/ICSI attempt, during pregnancy (including ectopic pregnancy occurrence) and at delivery (maternal and perinatal complications for mother and child until 6 weeks post-partum). To assess placental malposition occurrence (defined as the presence of placenta previa or accreta diagnosed on third trimester US examination or at time of delivery). ;Primary end point(s): The primary efficacy endpoint is a live birth after first or second IVF/ICSI attempt defined as delivery of one or more live-born infant. ;Timepoint(s) of evaluation of this end point: From 22 weeks of gestation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints include: -Uterine volume reduction between Ultra sound measurements: at baseline and at time of ovarian stimulation onset -Occurrence of poor responders defined as women with <3 matures follicles or serum estradiol <500 -Biochemical pregnancy defined as serum ßhCG = 100 IU/l -Implantation rate defined as the ratio ”number of gestational sacs/number of transferred embryos” on transvaginal ultrasound -Clinical pregnancy defined as the presence of one or more gestational sacs on transvaginal ultrasound -Clinical pregnancy with fetal heart beat defined as the presence of at least one fetus with heart beat on transvaginal ultrasound -Ongoing pregnancy defined as a live pregnancy on first trimester ultrasound examination -First trimester miscarriage occurrence defined as a pregnancy loss before 12 weeks of gestation among patients with a clinical pregnancy Secondary safety endpoints include: -Occurrence of menopause-like symptoms using the Menopause Rating Scale -Occurrence of ovarian hyperstimulation syndrome (OHS) -Occurrence of pregnancy and post-partum complications -Occurrence of neonatal complications -Occurrence of any other adverse Event ; Timepoint(s) of evaluation of this end point: -Uterine volume reduction:at baseline and at time of ovarian stimulation onset -Occurrence of poor responders:at the time of ovulation triggering -Biochemical pregnancy:14 days following follicular aspiration -Implantation rate and clinical pregnancy:5 weeks after follicular aspiration -Clinical pregnancy with fetal heart beat:7 weeks after embryo transfer -Ongoing pregn | — |
Countries
France
Contacts
Public Contactcaroline Peyrot
University Hospital Toulouse
Outcome results
None listed