MiscarriageNCT03940495
Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
An observational study of Miscarriage, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Miscarriage
- How many people
- 182 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Women who have a positive pregnancy test following IVF or frozen-thawed transfer
Who cannot join
- Women with renal failure are excluded due to assay interference with kisspeptin measurement
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Medical subject headings
- Abortion, Spontaneous
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (2)
Biochemical pregnancy
defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization
Measured: 8 weeks
Positive hCG level
conception is defined with the result of serum β-hCG ≥10 mIU/mL.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 May 2019
- Primary completion31 Dec 2019
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XIAOXI SUN, PHD, Study director, Shanghai JiAi Genetics & IVF Institute, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940495
- Sponsor's protocol ID
- JIAI 2019-04
- Status last verified
- Apr 2020
- First submitted
- 4 May 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 25376455Ammon 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.
PubMed 22511535Horne 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.
PubMed 21334129Jayasena 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.
PubMed 25127195Sullivan-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.
PubMed 29307393Li 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.
PubMed 37935913
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03940495
- Acronym / sponsor ID
- JIAI 2019-04
- Conditions
- Miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Women who have a positive pregnancy test following IVF or frozen-thawed transfer
Key exclusion criteria (1 listed)
- Women with renal failure are excluded due to assay interference with kisspeptin measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early miscarriage loss
Time frame: 10 weeks
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
2 secondary outcomes
Biochemical pregnancy
Time frame: 8 weeks
Positive hCG level
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 25376455Kolte 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.
- Background: PubMed 22511535Ammon 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.
- Background: PubMed 21334129Horne 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.
- Background: PubMed 25127195Jayasena 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.
- Background: PubMed 29307393Sullivan-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.
- Derived from this study: PubMed 37935913Li 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XIAOXI SUN, PHD study director
Shanghai JiAi Genetics & IVF Institute, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early miscarriage loss (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940495, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.