NCT04894136

Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 520 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Obstructive Azoospermia
• Non-obstructive Azoospermia
• Obstetric Complication

Interventions

Type	Name	Description
PROCEDURE	ICSI-TESE; embryo-transfer	The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.

Timeline

• Start date: 2001-01-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2021-05-20
• Last updated: 2021-05-20