Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate
The Live Birth Rate in Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle in Patients Undergoing Frozen-thawed Embryo Transfer
1 other identifier
interventional
840
0 countries
N/A
Brief Summary
Recent sutdies indicate that the existence of corpus lutein in the ovary is a key point to prevent preeclampsia, and patients undergoing FET with hormone replaced cycle have no corpus lutein and the absence of corpus lutein significantly increases the risk of preeclampsia in these patients. We aim to conduct a single center randomized trial study to compare the preeclampsia rate between the natural cycle and the hormone replaced cycle in patients undergoing FET.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
November 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2022
CompletedMarch 17, 2020
March 1, 2020
1.1 years
March 14, 2020
March 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
live birth rate
A delivery is considered successful live birth
delivery
Secondary Outcomes (1)
pre-eclampsia
From gestational week 20 to delivery
Study Arms (2)
natural cycle for endometrium preparation
OTHERpatients will have ovulation before embryo transfer
hormone replaced cycle for endometrium preparation
EXPERIMENTALpatients will do not have ovulation before embryo transfer
Interventions
patients will not use oral contraceptive drugs
patients will receive oral contraceptive drugs for menstruation before embryo transfer
Eligibility Criteria
You may qualify if:
- to 42 years old women;
- normal ovulation;
- Scheduled to undergo frozen-thawed embryo transfer.
- Agreeing with the informed consent.
You may not qualify if:
- Those who experienced embryo transfer cycle failure for at least three times;
- One or both of the ovaries removed;
- Hypertention disease before embryo transfer;
- No available embryo for transfer
- Oocyte or sperm donated cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Zhang, M.D. Ph.D.
Women's Hospital School Of Medicine Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2020
First Posted
March 17, 2020
Study Start
November 10, 2020
Primary Completion
December 10, 2021
Study Completion
March 10, 2022
Last Updated
March 17, 2020
Record last verified: 2020-03