Assisted reproductive technology (ART) and pregnancy outcomes in women with adenomyosis (internal endometriosis) according to stimulation protocol in relation to immunological and endometrial features: a prospective, randomized study - ADENOFERT

Azienda Ospedaliero Universitaria Di Modena0 sites500 target enrollmentJuly 16, 2024

Overview

No summary available.

Registry

who.int

Start Date

July 16, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sponsor

Azienda Ospedaliero Universitaria Di Modena

•Uterine adenomyosis diagnosed on ultrasound scan defined when at least ne of the following features is recognized: (1\) heterogeneous myometrium; (2\) hypoechoic striation in the myometrium; (3\) myometrial anechoic lacunae or cysts; (4\) asymmetrical myometrial thickening of the uterine walls. \- Couples requiring a cycle of IVF/ICSI meeting the criteria of the Italian law to be included in an ART program. \- Good physical and mental health (e.g. no contraindication to the therapeutic regimen for IVF/ICSI, like moderate or severe impairment of renal or hepatic function etc.). \- First or second IVF/ICSI attempt. \- Absence of severe premature ovarian insufficiency defined by antral follicle count \< 8 and AMH \< 1ng/ml. \- The female partner is \=18 and \< 42 years of age. \- The female partner has a BMI \<30\. \- Both partners are willing and able to provide written informed consent.

•\- Concurrent and/or recent involvement in other studies likely to interfere with the intervention within the previous 3 months of study enrolment. \- Other potential causes of implantation failure: leiomyoma, actual hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome \- A prior history of endometrial ablation, endometrial polyps, hydrosalpinx, smocking habits, known endometriosis stage III\-IV, abnormal uterine bleeding of unknown cause. \- Uterine fibroids (untreated FIGO Type 0\-I\-II and type III\-IV fibroids \> 3 cm) \- Use of GnRH analogues within previous 3 months. \- Extreme severe male factor infertility (sperm count \< 1 x 106/ml, use or surgically retrieved spermatozoa) \- 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 \- Couples who in the opinion of the researcher would be unable to give fully informed consent to the study.