Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?

Completed

• Conditions: Miscarriage

• Registration Number: NCT03940495
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-05-04
• Study First Submitted QC: 2019-05-04
• Study First Posted: 2019-05-07
• Primary Completion: 2019-12-31
• Status Verified: 2020-04
• Study Completion: 2020-08-01
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 182

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early miscarriage loss	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

Name	Time	Method
Biochemical pregnancy	8 weeks	defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization
Positive hCG level	4 weeks	conception is defined with the result of serum β-hCG ≥10 mIU/mL.

Trial Locations

Locations (1)

ShangHai JIAI Genetics&IVF Institute; 🇨🇳 Shanghai, China