Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

NCT ID: NCT03940495

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

182 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Miscarriage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XIAOXI SUN, PHD

Role: STUDY_DIRECTOR

Shanghai JiAi Genetics & IVF Institute, China

Locations

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ShangHai JIAI Genetics&IVF Institute

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25376455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22511535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21334129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25127195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29307393 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37935913 (View on PubMed)

Other Identifiers

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JIAI 2019-04

Identifier Type: -

Identifier Source: org_study_id

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