Skip to content

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516089-12-00
Acronym
ADENOFERT
Enrollment
500
Registered
2024-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women without adenomyosis but with similar baseline reproductive risks, women with transvaginal ultrasound (TV-US)-based diagnosis of adenomyosis

Brief summary

To prospectively investigate the association of Adenomyosis with fertility outcomes in relation to COH protocols for ART (long or ultra-long protocol) with a preventive high-dose anti-inflammatory progestin such as dienogest (DNG).

Detailed description

To evaluate the association of COH (Controlled Ovarian Hyperstimulation) protocols for ART (long or ultra-long protocol) with a high-dose preventive anti-inflammatory progestogen such as DNG with pregnancy and neonatal outcomes (preterm delivery, preeclampsia, cesarean section, fetal malformation, SGA, low birth weight and postpartum haemorrhage)., Secondary in-vitro sub-studies: Stimulated (P and DNG) markers of decidualization (osteopontin, prolactin) in relation to ART success in women with and without A. Immune system cell population and relative cytokines, the frequency of immune system cells, the interleukin profile, cell activity, specific receptors of pregnancy hormone involved in T cell activity in women with A in comparison to healthy subjects.

Interventions

DRUGLEUPRORELIN
DRUG-

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
To prospectively investigate the association of Adenomyosis with fertility outcomes in relation to COH protocols for ART (long or ultra-long protocol) with a preventive high-dose anti-inflammatory progestin such as dienogest (DNG).

Secondary

MeasureTime frame
To evaluate the association of COH (Controlled Ovarian Hyperstimulation) protocols for ART (long or ultra-long protocol) with a high-dose preventive anti-inflammatory progestogen such as DNG with pregnancy and neonatal outcomes (preterm delivery, preeclampsia, cesarean section, fetal malformation, SGA, low birth weight and postpartum haemorrhage)., Secondary in-vitro sub-studies: Stimulated (P and DNG) markers of decidualization (osteopontin, prolactin) in relation to ART success in women with and without A. Immune system cell population and relative cytokines, the frequency of immune system cells, the interleukin profile, cell activity, specific receptors of pregnancy hormone involved in T cell activity in women with A in comparison to healthy subjects.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026