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NCT03940495

Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

Completed Last updated 18 March 2021
What this trial tests

trial in Miscarriage in 182 participants. Completed in 1 August 2020.

Timeline
1 May 2019
Primary endpoint
31 December 2019
1 August 2020

Quick facts

Lead sponsorShangHai Ji Ai Genetics & IVF Institute
StatusCompleted
Study typeOBSERVATIONAL
Enrollment182
Start date1 May 2019
Primary completion31 December 2019
Estimated completion1 August 2020
Sites1 location across China

Conditions studied

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Who can join

Eligibility, female only, with Miscarriage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Kisspeptin a potential therapeutic target in treatment of both metabolic and reproductive dysfunction.
    Sliwowska JH, Woods NE, Alzahrani AR, Paspali E, et al · · 2024 · cited 9× · PMID 38599822 · DOI 10.1111/1753-0407.13541
  2. A prospective study to evaluate whether serum kisspeptin is a marker predictive of the first-trimester miscarriage of women who conceive in IVF.
    Li H, Zhang W, Sun X. · · 2024 · cited 1× · PMID 37935913 · DOI 10.1007/s10815-023-02974-x

Verify or expand the search:

Other recruiting trials for Miscarriage

Currently open trials in the same condition.

Other ShangHai Ji Ai Genetics & IVF Institute trials

Trials by the same sponsor.

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Data sources for this page

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