NCT04894136

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2001

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
19 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
Last Updated

May 20, 2021

Status Verified

March 1, 2021

Enrollment Period

19 years

First QC Date

April 16, 2021

Last Update Submit

May 16, 2021

Conditions

Obstructive AzoospermiaNon-obstructive AzoospermiaObstetric Complication

Keywords

Reproductive outcomes

Outcome Measures

Primary Outcomes (9)

  • 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)

Study Arms (2)

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

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

Interventions

ICSI-TESE; embryo-transferPROCEDURE

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 azoospermiaICSI-TESE cycles for obstructive azoospermia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 27198124BACKGROUND

  • 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.

    PMID: 20942727BACKGROUND

  • 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.

    PMID: 17184103BACKGROUND

  • 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.

    PMID: 10221707BACKGROUND

MeSH Terms

Interventions

Embryo Transfer

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

May 20, 2021

Study Start

January 1, 2001

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 20, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share