Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

NCT03940495 | Completed

• 1 other identifier: JIAI 2019-04
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Biochemical pregnancy

  8 weeks

• Positive hCG level

  4 weeks

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible women undergo ART treatment in our centre Shanghai JiAi Genetics \& IVF Institute will be recruited for the study and each woman will only be included in the study once. Informed written consent will be obtained.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Location

Related Publications (6)

• 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.

  PMID: 25376455 BACKGROUND

• 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.

  PMID: 22511535 BACKGROUND

• 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. No abstract available.

  PMID: 21334129 BACKGROUND

• 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.

  PMID: 25127195 BACKGROUND

• 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.

  PMID: 29307393 BACKGROUND

• Li H, Zhang W, Sun X. A prospective study to evaluate whether serum kisspeptin is a marker predictive of the first-trimester miscarriage of women who conceive in IVF. J Assist Reprod Genet. 2024 Jan;41(1):79-85. doi: 10.1007/s10815-023-02974-x. Epub 2023 Nov 8.

  PMID: 37935913 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum for hCG level is performed 14 days after embryo transfer i.e. week 4. If the serum hCG level is \>10IU/L, the women are considered pregnant and serum will be saved and checked for kisspeptin level, Blood test is repeated at 5 weeks and 6 weeks

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• XIAOXI SUN, PHD

  Shanghai JiAi Genetics & IVF Institute, China

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: August 1, 2020
• Last Updated: March 18, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)