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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
EU CTIS ID: 2024-516089-12-00
What this study is testing
Number of live birth after ART attempt defined as delivery of one or more live-born infant at >22 weeks of gestation in infertile women with adenomyosis vs. infertile women without adenomyosis.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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.
You likely can't join if
- - 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.