Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-06-06 @ 11:02 PM
Study NCT ID:
NCT03940495
Status:
COMPLETED
Last Update Posted:
2021-03-18
First Post:
2019-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-17', 'studyFirstSubmitDate': '2019-05-04', 'studyFirstSubmitQcDate': '2019-05-04', 'lastUpdatePostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early miscarriage loss', 'timeFrame': '10 weeks', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy', 'timeFrame': '8 weeks', 'description': 'defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization'}, {'measure': 'Positive hCG level', 'timeFrame': '4 weeks', 'description': 'conception is defined with the result of serum β-hCG ≥10 mIU/mL.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Miscarriage']}, 'referencesModule': {'references': [{'pmid': '25376455', 'type': 'BACKGROUND', '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.'}, {'pmid': '22511535', 'type': 'BACKGROUND', 'citation': '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': '21334129', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '25127195', 'type': 'BACKGROUND', '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.'}, {'pmid': '29307393', 'type': 'BACKGROUND', '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.'}, {'pmid': '37935913', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nBlood 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women who have a positive pregnancy test following IVF or frozen-thawed transfer\n\nExclusion Criteria:\n\n* Women with renal failure are excluded due to assay interference with kisspeptin measurement'}, 'identificationModule': {'nctId': 'NCT03940495', 'briefTitle': 'Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?', 'organization': {'class': 'OTHER', 'fullName': 'ShangHai Ji Ai Genetics & IVF Institute'}, 'officialTitle': 'A Prospective Study to Evaluate Whether Serum Kisspeptin is a Marker Predictive of the First Trimester Miscarriage of Women Who Conceive in IVF', 'orgStudyIdInfo': {'id': 'JIAI 2019-04'}}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'ShangHai JIAI Genetics&IVF Institute', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'XIAOXI SUN, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shanghai JiAi Genetics & IVF Institute, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ShangHai Ji Ai Genetics & IVF Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}