Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia (AZOOCOMES)

Istituto Clinico Humanitas

Status: Completed

Conditions: Obstructive Azoospermia; Obstetric Complication; Non-obstructive Azoospermia

Treatments: Procedure: ICSI-TESE; embryo-transfer

Study type: Observational

Funder types: Other

Identifiers

NCT04894136

1906 (Other Identifier)

Details and patient eligibility

About

A comparison of reproductive and obstetrical outcomes is retrospectively performed among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia between January 2001 and December 2019.

Full description

Azoospermia affects almost 20% of all infertile males and It can be divided into obstructive azoospermia (OA) and nonobstructive azoospermia (NOA). Assisted fertilization with testicular sperm extraction (TESE) and intracytoplasmatic sperm injection (ICSI) has been successfully applied for its treatment.

Review of the literature shows that there is a lack of consensus about reproductive outcomes between men with OA and NOA. No study has ever investigated differences in obstetrical outcomes between these two groups before.

The objective of this study is to retrospectively determine differences in reproductive and obstetrical outcomes among couples that underwent ICSI-TESE cycles for obstructive and non obstructive azoospermia.

The primary outcomes that will be investigated include:

• Reproductive outcomes: pregnancy rate, live birth rate (LBR) and abortion rate.
• Obstetrical outcomes: twinning rate, gestational age, prematurity rate, birth weight, cesarean section rate and the rate of the main obstetrical complication, such as pre-eclampsia, gestational hypertension, intrauterine growth restriction (IUGR).

Enrollment: 520 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for obstructive azoospermia group:

• infertility
• diagnosis of obstructive azoospermia
• ICSI-TESE cycles

Inclusion Criteria for non-obstructive azoospermia group:

• infertility
• diagnosis of non-obstructive azoospermia
• ICSI-TESE cycles

Exclusion Criteria:

• Sperm donation
• Use of ejaculated sperm
• Couples who underwent pre-implantation genetic testing

Trial design

520 participants in 2 patient groups

ICSI-TESE cycles for obstructive azoospermia

Description:

Couples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center

Treatment:

Procedure: ICSI-TESE; embryo-transfer

ICSI-TESE cycles for nonobstructive azoospermia

Description:

Couples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center

Treatment:

Procedure: ICSI-TESE; embryo-transfer