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

Phase 1

• Conditions: women with transvaginal ultrasound (TV-US)-based diagnosis of adenomyosis, women without adenomyosis but with similar baseline reproductive risks; MedDRA version: 20.0Level: SOCClassification code: 10038604Term: Reproductive system and breast disorders Class: 20; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]

• Registration Number: CTIS2024-516089-12-00
• Lead Sponsor: Azienda Ospedaliero Universitaria Di Modena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

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.

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified