Adenomyosis and ART

Summary

The goal of this clinical trial is 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 DNG and to assess their association with pregnancy and neonatal outcomes (preterm delivery,pre-eclampsia,Caesarean section,fetal malpresentation,small for gestational age,low birth weight and postpartum hemorrhage).
* Understand how the endometrial interface by studying the response of progesterone and DNG stimulated decidualization markers, correlating them with the success of ART protocol stimulation and to pregnancy specific outcomes
* Evaluate the immune changes during the implantation period and in the different trimesters of the pregnancies after ART conception.

Conditions

• Adenomyosis

Interventions

DRUG

Enantone

administration of depot leuprorelin 3.75 mg on day 21 of the previous luteal phase of the stimulation cycle.

DRUG

Dienogest 2 MG (milligram)

Before COH, patients will be treated with DNG at high dose (2 mg+2 mg/day) for 28 days, from the first day of previous menstrual cycle. COH will be performed using a long GnRH agonist protocol (administration of depot leuprorelin 3.75 mg on day 21 of the previous luteal phase of the stimulation cycle).

DRUG

Enantone

COH will be performed using a ultra-long GnRH agonist protocol (administration of the first depot leuprorelin 3.75 mg on day 21 of menstrual cycle, repeated after 28 days for other two times).

DRUG

long GnRH agonist or flexible GnRH antagonist protocol.

During TV-US monitoring, when at least one follicle reached 14 mm in diameter, to achieve LH suppression avoiding spontaneous ovulation, GnRH antagonist 0.25 mg/day will be added subcutaneously until the day of HCG administration.

Sponsors & Collaborators

• University of Modena and Reggio Emilia

  collaborator OTHER

• Ministero della Salute, Italy

  collaborator OTHER

• Azienda Ospedaliero-Universitaria di Modena

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

42 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-27

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Italy

Study Locations