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Completed

NCT Number: NCT03940495

Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

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.

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Key information

Conditions

Miscarriage Abortion, Spontaneous Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Sex eligibility

Female

Study type

Observational

Primary location

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

A Prospective Study to Evaluate Whether Serum Kisspeptin is a Marker Predictive of the First Trimester Miscarriage of Women Who Conceive in IVF

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
May 7, 2019
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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