In short
Currently, there is 1 clinical trial exploring treatment options for women with adenomyosis who are seeking to become pregnant through assisted reproductive technology. This trial is investigating how hormone medications combined with fertility treatments can improve pregnancy outcomes in women affected by this condition.
Clinical trial locations
Study of leuprorelin and progestogen treatment in women with adenomyosis undergoing assisted reproductive technology to improve pregnancy outcomes
This clinical trial is being conducted in Italy and focuses on improving pregnancy outcomes for women with adenomyosis who are undergoing fertility treatments. Adenomyosis is a condition where tissue that normally lines the uterus grows into the muscular wall of the uterus, which can cause heavy periods, pain, and difficulties with fertility.
Main inclusion criteria:
- Women aged between 18 and 42 years
- Either confirmed diagnosis of adenomyosis through transvaginal ultrasound, or women without adenomyosis but with similar reproductive challenges
- Body mass index below 30
- Undergoing first or second IVF or ICSI fertility treatment attempt
- Adequate ovarian function with at least 8 antral follicles and AMH hormone level of 1 ng/ml or higher
- Good physical and mental health suitable for fertility treatment
- Meeting Italian legal requirements for assisted reproductive technology
Main exclusion criteria:
- Age below 18 or above 45 years
- Male patients, as the study is for women only
- Currently pregnant
- Unable to provide informed consent
- Participating in other clinical trials
- Medical conditions that could interfere with fertility treatment
- History of severe allergic reactions to fertility medications
- Presence of other significant uterine conditions
Focus and goal of the trial:
The main purpose of this study is to determine how successful fertility treatments are in achieving live births in women with adenomyosis compared to those without the condition. The research examines different treatment approaches and their effects on pregnancy outcomes. Participants will be randomly assigned to either a "long" or "ultra-long" treatment protocol, both of which include dienogest, a medication that helps reduce inflammation.
The study follows a structured approach starting with confirmation of diagnosis through ultrasound, followed by treatment group assignment and medication administration. Participants then undergo controlled ovarian stimulation as part of the fertility treatment, followed by either in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Throughout any resulting pregnancy, regular monitoring continues to track outcomes including pregnancy progress and birth results.
Investigational drugs:
The study uses leuprorelin acetate, a hormone medication administered through injection at doses up to 3 mg daily, and progestogen medication taken orally at doses up to 4 mg daily. These medications are combined with standard fertility treatment protocols. The research also examines how the body's immune system responds to these treatments.
Summary
Currently, there is only one ongoing clinical trial specifically targeting pregnancy outcomes in women with adenomyosis. This trial is being conducted in Italy and represents an important effort to understand how hormone-based treatments can improve fertility success rates for women affected by this condition. The study focuses on comparing outcomes between women with and without adenomyosis using established hormone medications in combination with assisted reproductive technology. The research takes a comprehensive approach by examining both treatment effectiveness and immune system responses, which may provide valuable insights into optimizing fertility treatment protocols for women with adenomyosis.
