Serum Kisspeptin: a Predictive Marker of Miscarriage or Not?
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| ClinicalTrials.gov Identifier: NCT03940495 |
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Recruitment Status :
Completed
First Posted : May 7, 2019
Last Update Posted : March 18, 2021
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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 |
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| Miscarriage |
| 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 1, 2019 |
| Actual Primary Completion Date : | December 31, 2019 |
| Actual Study Completion Date : | August 1, 2020 |
- 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
- Biochemical pregnancy [ Time Frame: 8 weeks ]defined as pregnancy demise based on decreasing serum or urinary beta-HCG levels, without ultrasound visualization
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940495
| China | |
| ShangHai JIAI Genetics&IVF Institute | |
| Shanghai, China | |
| Study Director: | XIAOXI SUN, PHD | Shanghai JiAi Genetics & IVF Institute, China |
| Responsible Party: | ShangHai Ji Ai Genetics & IVF Institute |
| ClinicalTrials.gov Identifier: | NCT03940495 |
| Other Study ID Numbers: |
JIAI 2019-04 |
| First Posted: | May 7, 2019 Key Record Dates |
| Last Update Posted: | March 18, 2021 |
| Last Verified: | April 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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). |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Abortion, Spontaneous Pregnancy Complications |