Clinical trial NCT04894136: Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia
Official title: Reproductive and Obstetric Outcomes in TESE-ICSI Cycles: a Comparison Between Obstructive and Non-obstructive Azoospermia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Azoospermia
Non-obstructive Azoospermia
Obstetric Complication
Keywords: Reproductive outcomes
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Live birth rate (LBR)
timeFrame: 20 years (2001-2019)
measure: Pregnancy rate
timeFrame: 20 years (2001-2019)
measure: Abortion rate
timeFrame: 20 years (2001-2019)
measure: Maternal complications rate
timeFrame: 20 years (2001-2019)
measure: Gestational age
timeFrame: 20 years (2001-2019)
measure: Prematurity rate
timeFrame: 20 years (2001-2019)
measure: Twinning rate
timeFrame: 20 years (2001-2019)
measure: Cesarean section rate
timeFrame: 20 years (2001-2019)
measure: Birth weight
timeFrame: 20 years (2001-2019)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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.
citation: 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.