Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

Completed

• Conditions: Obstructive Azoospermia; Non-obstructive Azoospermia; Obstetric Complication
• Interventions: Procedure: ICSI-TESE; embryo-transfer

• Registration Number: NCT04894136
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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).

Study Timeline

• Study Start: 2001-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-03
• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-05-16
• Last Update Submitted: 2021-05-16
• Study First Posted: 2021-05-20
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICSI-TESE cycles for obstructive azoospermia	ICSI-TESE; embryo-transfer	Couples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center
ICSI-TESE cycles for nonobstructive azoospermia	ICSI-TESE; embryo-transfer	Couples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center

Primary Outcome Measures

Name	Time	Method
Live birth rate (LBR)	20 years (2001-2019)	Rate of delivery of a living baby after at least 22 weeks of gestation
Abortion rate	20 years (2001-2019)	Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation
Pregnancy rate	20 years (2001-2019)	Total number of pregnancies including live births, abortions and fetal death
Gestational age	20 years (2001-2019)	Mean gestational age of the pregnancies considered (written with both weeks and days)
Maternal complications rate	20 years (2001-2019)	Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.
Twinning rate	20 years (2001-2019)	Rate of twin deliveries out of the total number of deliveries
Cesarean section rate	20 years (2001-2019)	Rate of cesarean section deliveries out of the total number of deliveries
Prematurity rate	20 years (2001-2019)	Rate of pregnancies lasted less than 37 weeks and 0 days
Birth weight	20 years (2001-2019)	Mean birth weight of the neonates written in grams.