Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

Obstetric Complication Clinical Trial

— AZOOCOMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894136
• Other study ID #: 1906
• Status: Completed
• Start date: January 1, 2001
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Azoospermia
• Non-obstructive Azoospermia
• Obstetric Complication

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Palermo GD, Schlegel PN, Hariprashad JJ, Ergün 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate (LBR)	Rate of delivery of a living baby after at least 22 weeks of gestation	20 years (2001-2019)
Primary	Pregnancy rate	Total number of pregnancies including live births, abortions and fetal death	20 years (2001-2019)
Primary	Abortion rate	Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation	20 years (2001-2019)
Primary	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)
Primary	Gestational age	Mean gestational age of the pregnancies considered (written with both weeks and days)	20 years (2001-2019)
Primary	Prematurity rate	Rate of pregnancies lasted less than 37 weeks and 0 days	20 years (2001-2019)
Primary	Twinning rate	Rate of twin deliveries out of the total number of deliveries	20 years (2001-2019)
Primary	Cesarean section rate	Rate of cesarean section deliveries out of the total number of deliveries	20 years (2001-2019)
Primary	Birth weight	Mean birth weight of the neonates written in grams.	20 years (2001-2019)