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Completed

NCT Number: NCT04894136

Reproductive and Obstetric Outcomes in TESE-ICSI Cycles for 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.

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Key information

Conditions

Obstructive Azoospermia Non-obstructive Azoospermia Obstetric Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICSI-TESE; embryo-transfer

Procedure

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

Primary outcomes

  1. Live birth rate (LBR)

    Time frame: 20 years (2001-2019)

    Rate of delivery of a living baby after at least 22 weeks of gestation

  2. Pregnancy rate

    Time frame: 20 years (2001-2019)

    Total number of pregnancies including live births, abortions and fetal death

  3. Abortion rate

    Time frame: 20 years (2001-2019)

    Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation

  4. Maternal complications rate

    Time frame: 20 years (2001-2019)

    Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension, placenta previa and placental abruption, intrauterine growth restriction.

  5. Gestational age

    Time frame: 20 years (2001-2019)

    Mean gestational age of the pregnancies considered (written with both weeks and days)

  6. Prematurity rate

    Time frame: 20 years (2001-2019)

    Rate of pregnancies lasted less than 37 weeks and 0 days

  7. Twinning rate

    Time frame: 20 years (2001-2019)

    Rate of twin deliveries out of the total number of deliveries

  8. Cesarean section rate

    Time frame: 20 years (2001-2019)

    Rate of cesarean section deliveries out of the total number of deliveries

  9. Birth weight

    Time frame: 20 years (2001-2019)

    Mean birth weight of the neonates written in grams.

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Acronym: AZOOCOMES

Important dates

Study start
2001
Primary completion
2019
Study completion
2019
First posted
May 20, 2021
Registry last updated
May 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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