Investigating the impact of adenomyosis on fertility outcomes during assisted reproductive technology
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
This study is testing how adenomyosis affects pregnancy success in women using assisted reproductive technology by comparing different treatment methods to see which one works best.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 1 site (Modena) |
| Trial ID | NCT05937490 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to explore how adenomyosis affects fertility outcomes in women undergoing assisted reproductive technology (ART). It will compare different controlled ovarian hyperstimulation (COH) protocols, including a long protocol and an ultra-long protocol, with the addition of a high-dose anti-inflammatory progestin, dienogest (DNG). The study will assess pregnancy and neonatal outcomes, as well as immune changes during the implantation period. A total of 500 women will be enrolled, including those with adenomyosis and healthy controls, to evaluate the effectiveness of these approaches in achieving live births.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 42 with a diagnosis of adenomyosis who are undergoing their first or second IVF/ICSI attempt.
Not a fit: Patients with severe premature ovarian insufficiency or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve fertility outcomes and pregnancy safety for women with adenomyosis undergoing ART.
How similar studies have performed: While there is ongoing research into adenomyosis and fertility, this specific approach combining COH protocols with high-dose progestin is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adenomyosis of the uterus defined with at least one of the following features: (1) heterogeneous myometrium; (2) hypoechoic striation in the myometrium; (3) myometrial anechoic lacunae or cysts; (4) asymmetrical myometrial thickening of the uterine walls. * Couples who are undergoing a cycle of IVF/ICSI, where a cycle is defined as egg collection following ovarian stimulation. * First or second IVF or ICSI attempt. * Absence of severe premature ovarian insufficiency defined by antral follicle count \< 8 and AMH (anti-mullerian hormone) \< 1ng/ml * Meet the criteria from the Italian law to be included in a ART program. * 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 research that is likely to interfere with the intervention within the previous 3 months of study enrolment. * Other potential causes of implantation failure: in situ leiomyoma, hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome * Uterine fibroids (untreated FIGO, International Federation of Gynecology and Obstetrics, Type 0-I-II and type III-IV fibroids \> 3 cm) * Use of GnRH analogues within previous 3 months. * Extremely severe male factor infertility (sperm count \< 1x 10 6 /ml, use o 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 unable to give fully informed consent to the study.
Where this trial is running
Modena
- Azienda Ospedaliero-Universitaria di Modena — Modena, Italy (Recruiting)
Study contacts
- Study coordinator: Facchinetti Fabio, Medical Doctor (MD)
- Email: facchi@unimore.it/fabio.facchinetti@unimore.it
- Phone: 0594222512/3335824079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.