NCT04852237

Brief Summary

The objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after ICSI (intracytoplasmic sperm injection)-TESE (testicular sperm extraction) for obstructive azoospermia. The primary outcomes that will be investigated include:

  • Maternal outcomes: live birth rate (LBR), abortion rate, and the rate of the main obstetrics complication, such as pre-eclampsia, gestational hypertension and diabetes mellitus.
  • Neonatal outcomes: gestational age, prematurity rate, birth weight, sex ratio, 1- and 5-min APGAR, birth defects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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, 2010

Completed
10 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
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
Last Updated

April 22, 2021

Status Verified

April 1, 2021

Enrollment Period

10 years

First QC Date

March 30, 2021

Last Update Submit

April 20, 2021

Conditions

Obstructive AzoospermiaObstetric Complication

Keywords

Neonatal outcomes

Outcome Measures

Primary Outcomes (9)

  • Live birth rate (LBR)

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

    10 years

  • Abortion Rate (AR)

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

    10 years

  • Maternal complications rate

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

    10 years

  • Gestational age

    Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)

    10 years

  • Prematurity rate

    Rate of pregnancies lasted less than 37 weeks and 0 days

    10 years

  • Birth weight

    Mean birth weight of the neonates, written in grams.

    10 years

  • Sex ratio

    Ratio between males and females among the newborns

    10 years

  • 1- and 5-min APGAR

    Objective score of the condition of a baby after birth, at 1 and 5 minutes from the delivery (from 1 to 10 points).

    10 years

  • Incidence of congenital defects

    Incidence of congenital malformations, deformations and chromosomal abnormalities among the newborns of the study group (eg. clubfoot deformity, anorectal malformations, heart defects, ...)

    10 years

Study Arms (2)

Pregnancies from ICSI-TESE cycles for obstructive azoospermia.

Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia.

Pregnancies from ICSI cycles with ejaculated sperm.

Pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI cycles with ejaculated sperm.

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study database will include all the pregnancies occurred between January 2010 and December 2019 at Humanitas Fertility Center after ICSI-TESE cycles for obstructive azoospermia. A comparison of maternal and neonatal outcomes will be performed among the above-mentioned pregnancies and pregnancies from ICSI cycles with ejaculated sperm of couples with different indications occurred in the same period of time. The controls will be matched to the cases for the principal risk factors for adverse maternal and neonatal outcomes (maternal age, BMI) with a ratio of 1:2.

You may qualify if:

  • primary infertility
  • diagnosis of obstructive azoospermia
  • ICSI-TESE cycles
  • primary infertility
  • ICSI cycles with sperm from ejaculate

You may not qualify if:

  • pre-gestational hypertension
  • pre-gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Robertson SA, Sharkey DJ. Seminal fluid and fertility in women. Fertil Steril. 2016 Sep 1;106(3):511-9. doi: 10.1016/j.fertnstert.2016.07.1101. Epub 2016 Jul 30.

    PMID: 27485480BACKGROUND

  • Verwoerd GR, Hall DR, Grove D, Maritz JS, Odendaal HJ. Primipaternity and duration of exposure to sperm antigens as risk factors for pre-eclampsia. Int J Gynaecol Obstet. 2002 Aug;78(2):121-6. doi: 10.1016/s0020-7292(02)00130-3.

    PMID: 12175712BACKGROUND

  • Wang JX, Knottnerus AM, Schuit G, Norman RJ, Chan A, Dekker GA. Surgically obtained sperm, and risk of gestational hypertension and pre-eclampsia. Lancet. 2002 Feb 23;359(9307):673-4. doi: 10.1016/S0140-6736(02)07804-2.

    PMID: 11879865BACKGROUND

  • Di Mascio D, Saccone G, Bellussi F, Vitagliano A, Berghella V. Type of paternal sperm exposure before pregnancy and the risk of preeclampsia: A systematic review. Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:246-253. doi: 10.1016/j.ejogrb.2020.05.065. Epub 2020 Jun 1.

    PMID: 32544753BACKGROUND

  • Dekker G, Robillard PY, Roberts C. The etiology of preeclampsia: the role of the father. J Reprod Immunol. 2011 May;89(2):126-32. doi: 10.1016/j.jri.2010.12.010. Epub 2011 May 6.

    PMID: 21529966BACKGROUND

  • Andraweera P, Roberts CT, Leemaqz S, McCowan L, Myers J, Kenny LC, Walker J, Poston L, Dekker G; SCOPE Consortium. The duration of sexual relationship and its effects on adverse pregnancy outcomes. J Reprod Immunol. 2018 Aug;128:16-22. doi: 10.1016/j.jri.2018.05.007. Epub 2018 May 18.

    PMID: 29803191BACKGROUND

  • Klonoff-Cohen HS, Savitz DA, Cefalo RC, McCann MF. An epidemiologic study of contraception and preeclampsia. JAMA. 1989 Dec 8;262(22):3143-7.

    PMID: 2810672BACKGROUND

  • Robillard PY, Dekker G, Chaouat G, Hulsey TC, Saftlas A. Epidemiological studies on primipaternity and immunology in preeclampsia--a statement after twelve years of workshops. J Reprod Immunol. 2011 May;89(2):104-17. doi: 10.1016/j.jri.2011.02.003. Epub 2011 May 4.

    PMID: 21543120BACKGROUND

  • Jin L, Li Z, Gu L, Huang B. Neonatal outcome of children born after ICSI with epididymal or testicular sperm: A 10-year study in China. Sci Rep. 2020 Mar 20;10(1):5145. doi: 10.1038/s41598-020-62102-y.

    PMID: 32198466BACKGROUND

  • Belva F, De Schrijver F, Tournaye H, Liebaers I, Devroey P, Haentjens P, Bonduelle M. Neonatal outcome of 724 children born after ICSI using non-ejaculated sperm. Hum Reprod. 2011 Jul;26(7):1752-8. doi: 10.1093/humrep/der121. Epub 2011 Apr 21.

    PMID: 21511713BACKGROUND

Study Design

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

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 21, 2021

Study Start

January 1, 2010

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 22, 2021

Record last verified: 2021-04