Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes?

Obstetric Complication Clinical Trial

Official title:

Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes? A 10 Years Single-center Experience Comparing ICSI-TESE Pregnancies From ICSI Pregnancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04852237
• Other study ID #: 1916
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Several studies investigated the role of paternal factors in the development of preeclampsia; in particular, they analyzed the correlation between the vaginal exposure to male partner's semen and the incidence of preeclampsia, observing both a reduced risk of preeclampsia after prolonged exposure to the paternal seminal fluid and a higher incidence of preeclampsia in pregnancies conceived with a new father or with sperm donor. This leads to the hypothesis of an immunological role for sperm in inducing a mucosal immune tolerance-like status at the level of the uterus that could be critical in the subsequent implantation.

Previous studies also examined the neonatal outcomes from pregnancies obtained from surgically retrieved sperm, either epididymal or testicular sperm, and underlined that there is not overall increased risk in neonatal outcomes.

Our study aims at having a complete view on paternal, maternal and neonatal information and a follow up, that allows to correct possible confounders and to analyze a wider group of outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria for case arm:

• primary infertility

• diagnosis of obstructive azoospermia

• ICSI-TESE cycles

Inclusion Criteria for control arm:

• primary infertility

• ICSI cycles with sperm from ejaculate

Exclusion Criteria:

• pre-gestational hypertension

• pre-gestational diabetes

Related Conditions & MeSH terms

• Azoospermia
• Obstetric Complication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

Verwoerd GR, Hall DR, Grové 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate (LBR)	Rate of delivery of a living baby after at least 22 weeks of gestation	10 years
Primary	Abortion Rate (AR)	Proportion of clinical pregnancies who failed to continue beyond 22 weeks of gestation	10 years
Primary	Maternal complications rate	Incidence of the obstetric complications, such as pre-eclampsia, gestational hypertension and diabetes, placenta previa and placental abruption.	10 years
Primary	Gestational age	Mean gestational age of the pregnancies considered (written with both weeks and days; eg, 39 weeks and 0 days)	10 years
Primary	Prematurity rate	Rate of pregnancies lasted less than 37 weeks and 0 days	10 years
Primary	Birth weight	Mean birth weight of the neonates, written in grams.	10 years
Primary	Sex ratio	Ratio between males and females among the newborns	10 years
Primary	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
Primary	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