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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Complication; Non-obstructive Azoospermia; Obstructive Azoospermia
• Intervention / Treatment: Procedure: ICSI-TESE; embryo-transfer

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 Type: Observational
• Enrollment (Actual): 520

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study database will include all the couples who underwent ICSI-TESE cycles between January 2001 and December 2019 at Humanitas Fertility Center after ICSI-TESE for obstructive and nonobstructive azoospermia.

ICSI-TESE cycles not reaching the stage of oocyte retrieval will be excluded.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ICSI-TESE cycles for obstructive azoospermia; Couples who underwent ICSI-TESE cycles for obstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center	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.
ICSI-TESE cycles for nonobstructive azoospermia; Couples who underwent ICSI-TESE cycles for nonobstructive azoospermia between January 2001 and December 2019 at Humanitas Fertility Center	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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Publications and helpful links

General Publications

• Bocca S, Moussavi V, Brugh V, Morshedi M, Stadtmauer L, Oehninger S. ICSI outcomes in men undergoing TESE for azoospermia and impact of maternal age. Andrologia. 2017 Mar;49(2). doi: 10.1111/and.12617. Epub 2016 May 20.
• He X, Cao Y, Zhang Z, Zhao J, Wei Z, Zhou P, Cong L. Spermatogenesis affects the outcome of ICSI for azoospermic patients rather than sperm retrieval method. Syst Biol Reprod Med. 2010 Dec;56(6):457-64. doi: 10.3109/19396368.2010.513078. Epub 2010 Oct 14.
• La Sala GB, Valli B, Leoni S, Pescarini M, Martino F, Nicoli A. Testicular sperm aspiration (TESA) in 327 ICSI cycles. Int J Fertil Womens Med. 2006 Jul-Aug;51(4):177-82.
• Palermo GD, Schlegel PN, Hariprashad JJ, Ergun B, Mielnik A, Zaninovic N, Veeck LL, Rosenwaks Z. Fertilization and pregnancy outcome with intracytoplasmic sperm injection for azoospermic men. Hum Reprod. 1999 Mar;14(3):741-8. doi: 10.1093/humrep/14.3.741.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2001
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: May 16, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Reproductive outcomes
• Additional Relevant MeSH Terms: Infertility, Male; Infertility; Azoospermia
• Other Study ID Numbers: 1906 (Assiut Univeristy Faculty of Medicine Ethical Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No