Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for Azoospermia

NCT ID: NCT04894136

Last Updated: 2021-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Obstructive Azoospermia Non-obstructive Azoospermia Obstetric Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

ICSI-TESE; embryo-transfer

Intervention Type PROCEDURE

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

ICSI-TESE; embryo-transfer

Intervention Type PROCEDURE

The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* infertility
* diagnosis of obstructive azoospermia
* ICSI-TESE cycles


* infertility
* diagnosis of non-obstructive azoospermia
* ICSI-TESE cycles

Exclusion Criteria

* Sperm donation
* Use of ejaculated sperm
* Couples who underwent pre-implantation genetic testing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 27198124 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20942727 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17184103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10221707 (View on PubMed)

Other Identifiers

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1906

Identifier Type: -

Identifier Source: org_study_id

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