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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03940807
Recruitment Status Not yet recruiting
First Posted May 7, 2019
Last update posted March 15, 2021
Adenomyosis is a benign condition defined as the invasion of ectopic endometrium into the myometrium, resulting in smooth muscle hyperplasia and endometrial inflammation, commonly associated with endometriosis and uterine fibroids. Heterogeneity among studies regarding diagnostic criteria and therapeutic management has fed the debate surrounding the impact of adenomyosis on assisted reproductive therapy outcomes. Nevertheless, recent data support that adenomyosis impairs reproductive outcomes associated with in vitro fertilization (IVF). According to several experimental data, prolonged exposure to gonadotropin releasing hormone (GnRH) agonists may overcome part of the detrimental impact of adenomyosis on fertility outcome. Overall, GnRH agonist treatment resulted in decreased local production of cytochrome P450 aromatase, decreased intrauterine concentration of free radicals and reduced inflammatory response and angiogenesis in endometrium, myometrium and adenomyosis lesions. At the same time, GnRH agonists affect neither endometrial capacity to support invasion nor invasive potential of the blastocyst in the early stages of implantation. For IVF, 2 main protocols based on GnRH agonist pituitary down-regulation are available: - the long protocol involving a 15 days pituitary down-regulation; - the ultra-long protocol involving a 3 months pituitary down-regulation. Most studies using ultra-long protocol reported similar IVF outcomes in adenomyosis patients and control groups. Conversely, studies involving long or GnRH antagonist protocols demonstrated a significant reduction in clinical and ongoing pregnancy rates in adenomyosis patients compared to control subjects. Thus supporting that ultra-long protocol may be beneficial to improve IVF outcomes in the setting of adenomyosis.This is what investigators would like to demonstrate in this study
|Experimental: Ultra-long protocol group
All women will receive one intra-muscular administration of 11.25 mg Gonadotropin Releasing Hormone (GnRH) agonist (triptorelin acetate) on luteal phase of their menstrual cycle. Add back therapy (transdermal estradiol, 25μg twice a week) will be administrated throughout down-regulation period. Ovarian stimulation will be started after 90 days desensitization.
Drug: 11.25mg GnRH agonist
Ultra-long protocol group women will receive one intra-muscular administration of 11.25 mg GnRH agonist (triptorelin acetate) on the luteal phase of their menstrual cycle. Ovarian stimulation will be started after 90 days desensitization. After the desensitization period, all patients will undergo standardized ovarian stimulation, follicular aspiration, fertilization of all oocytes using either standard insemination or ICSI according to the features of sperm examination, fresh embryo transfer and luteal phase support.
Drug: 25 µg transdermal oestradiol
Add back therapy (transdermal estradiol, 25μg twice a week) will be administrated throughout down-regulation period.
|Active Comparator: Long protocol group
All women will receive a 15-days pituitary down-regulation protocol that consists of daily subcutaneous application of 0.1mg of GnRH agonist (triptorelin acetate) started on luteal phase of their menstrual cycle. Ovarian stimulation will begin after 15 days desensitization.
Drug: 0.1 mg GnRH agonist
Long protocol group women will receive a 15-days pituitary down-regulation protocol that consists of daily subcutaneous injection of 0.1mg of GnRH agonist (triptorelin acetate) started on the luteal phase of their menstrual cycle. Ovarian stimulation will begin after 15 days desensitization. After the desensitization period, all patients will undergo standardized ovarian stimulation, follicular aspiration, fertilization of all oocytes using either standard insemination or ICSI according to the features of sperm examination, fresh embryo transfer and luteal phase support.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
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 (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.
Contact: Fabien Vidal, MD 05 67 77 13 70 firstname.lastname@example.org
Contact: Celia Bettiol, CRA 05 67 77 13 87 email@example.com
Centre Aliénor d'Aquitaine
Centre hospitalier intercommunal de Créteil
Hôpital de la Conception Marseille
CHU Rouen Normandie
Centre hospitalier des 4 villes
University Hospital, Toulouse
Principal Investigator: Fabien Vidal CHU Toulouse