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Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

  • Clinicaltrials.gov identifier

    NCT03940495

  • Recruitment Status

    Completed

  • First Posted

    May 7, 2019

  • Last update posted

    March 18, 2021

Study Description

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.

  • Condition or Disease:Miscarriage
  • Intervention/Treatment:
  • Phase: N/A

Detailed Description

N/A

Study Design

  • Study Type: Observational
  • Actual Enrollment: 182 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: August 2020

Outcome Measures

  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. Biochemical pregnancy [ Time Frame: 8 weeks ]
    defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization
  • 2. Positive hCG level [ Time Frame: 4 weeks ]
    conception is defined with the result of serum β-hCG ≥10 mIU/mL.
  • 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

Eligibility Criteria

  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • 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.

Criteria

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

Contacts and Locations

Contacts

Locations

China
ShangHai JIAI Genetics&IVF Institute
Shanghai

Sponsors and Collaborators

ShangHai Ji Ai Genetics & IVF Institute

Investigators

Study Director: XIAOXI SUN, PHD Shanghai JiAi Genetics & IVF Institute, China

More Information