Clinical trial: Impact of Ultra-long Versus Long Down-regulation Protocol on IVF/ICSI in Adenomyosis (NCT03940807)

Eligibility criteria:
Inclusion Criteria:

          1. suspected adenomyosis on high quality transvaginal ultrasound or focal or diffuse
             adenomyosis defined as a thickening of the junctional zone to more than 12mm on
             previous magnetic resonance Imaging (<6 months)

          2. infertility of any cause requiring IVF or ICSI

          3. infertility period of at least 1 year except for women with history of deep
             infiltrating endometriosis or bilateral salpingectomy

          4. age >18 and < 40 years

          5. complete fertility workup comprising for women hormone serum measurement
             (anti-mullerian hormone (AMH), estradiol, follicle stimulating hormone (FSH),
             luteinizing hormone (LH)), high quality transvaginal ultrasound and, when applicable,
             hysterosalpingography, diagnostic laparoscopy or hysteroscopy

          6. first or second IVF or ICSI attempt

          7. absence of severe premature ovarian insufficiency defined by antral follicle count < 8
             and AMH < 1ng/ml

          8. meet the criteria from the French law to be included in an assisted reproductive
             technique program

          9. informed written consent for both women and men

         10. social security cover for both women and men

        Exclusion Criteria:

          1. absence of adenomyosis (defined as a thickening of the junctional zone 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. women taking prohibited concomitant treatments and not able to stop them for the study
             period

          5. 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

          6. positive plasma viral load for human immunodeficiency virus(HIV), hepatitis C virus
             (HCV) or hepatitis B virus (HBV) for one (or both) in the couple during the year
             before inclusion

          7. participation in another research study including an exclusion period which has not
             expired at the time of screening

          8. patients subject to a judicial safeguard order, guardianship or trusteeship.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years

Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? 0