Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

Miscarriage Clinical Trial

Official title:

A Prospective Study to Evaluate Whether Serum Kisspeptin is a Marker Predictive of the First Trimester Miscarriage of Women Who Conceive in IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940495
• Other study ID #: JIAI 2019-04
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2020
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective observational study. Eligible women undergo ART treatment in our centre will be recruited for the study and each woman will only be included in the study once. Informed written consent will be obtained. Blood serum for hCG level is performed 14 days after the embryo transfer i.e. week 4. If the serum hCG level is >10IU/L, the women are considered pregnant and blood will be saved and checked for kisspeptin level, Another blood test is repeated 1 week later i.e. week 5. A transvaginal ultrasound and blood test will be performed 1 week later i.e. week 6 to confirm the fetal viability and the number of gestational sacs and locate the pregnancy. Blood for hCG and kisspeptin levels are checked at weeks, 4, 5 and 6. Ultrasound will be performed at gestational 8 weeks and 11 weeks. They will be referred for antenatal care when the pregnancy is confirmed on-going at 11 weeks. The purpose is to determine whether serum kisspeptin level in women who conceive in IVF is associated with an increased risk in first trimester miscarriage and compare with serum hCG level in the prediction of the first trimester miscarriage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: August 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women who have a positive pregnancy test following IVF or frozen-thawed transfer

Exclusion Criteria:

• Women with renal failure are excluded due to assay interference with kisspeptin measurement

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Locations

Country	Name	City	State
China	ShangHai JIAI Genetics&IVF Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (5)

Ammon Avalos L, Galindo C, Li DK. A systematic review to calculate background miscarriage rates using life table analysis. Birth Defects Res A Clin Mol Teratol. 2012 Jun;94(6):417-23. doi: 10.1002/bdra.23014. Epub 2012 Apr 18. Review. — View Citation

Horne AW, McBride R, Denison FC. Normally rising hCG does not predict live birth in women presenting with pain and bleeding in early pregnancy. Eur J Obstet Gynecol Reprod Biol. 2011 May;156(1):120-1. doi: 10.1016/j.ejogrb.2011.01.013. Epub 2011 Feb 18. — View Citation

Jayasena CN, Abbara A, Izzi-Engbeaya C, Comninos AN, Harvey RA, Gonzalez Maffe J, Sarang Z, Ganiyu-Dada Z, Padilha AI, Dhanjal M, Williamson C, Regan L, Ghatei MA, Bloom SR, Dhillo WS. Reduced levels of plasma kisspeptin during the antenatal booking visit are associated with increased risk of miscarriage. J Clin Endocrinol Metab. 2014 Dec;99(12):E2652-60. doi: 10.1210/jc.2014-1953. — View Citation

Kolte AM, Bernardi LA, Christiansen OB, Quenby S, Farquharson RG, Goddijn M, Stephenson MD; ESHRE Special Interest Group, Early Pregnancy. Terminology for pregnancy loss prior to viability: a consensus statement from the ESHRE early pregnancy special interest group. Hum Reprod. 2015 Mar;30(3):495-8. doi: 10.1093/humrep/deu299. Epub 2014 Nov 5. Review. — View Citation

Sullivan-Pyke C, Haisenleder DJ, Senapati S, Nicolais O, Eisenberg E, Sammel MD, Barnhart KT. Kisspeptin as a new serum biomarker to discriminate miscarriage from viable intrauterine pregnancy. Fertil Steril. 2018 Jan;109(1):137-141.e2. doi: 10.1016/j.fertnstert.2017.09.029. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early miscarriage loss	defined as intrauterine pregnancy loss at less than 10 weeks' gestation as identified by ultrasound, including identification of empty sac, miscarriage, yolk sac miscarriage and embryonic miscarriage	10 weeks
Secondary	Biochemical pregnancy	defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization	8 weeks
Secondary	Positive hCG level	conception is defined with the result of serum ß-hCG =10 mIU/mL.	4 weeks