Back to resultsNatural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate
Primary Purpose
Pre-Eclampsia
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
natural cycle for endometrium preparation
hormone replaced cycle for endometrium preparation
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Eclampsia
Eligibility Criteria
Inclusion Criteria:
- 18 to 42 years old women;
- normal ovulation;
- Scheduled to undergo frozen-thawed embryo transfer.
- Agreeing with the informed consent.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
natural cycle for endometrium preparation
hormone replaced cycle for endometrium preparation
Arm Description
patients will have ovulation before embryo transfer
patients will do not have ovulation before embryo transfer
Outcomes
Primary Outcome Measures
live birth rate
A delivery is considered successful live birth
Secondary Outcome Measures
pre-eclampsia
Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)
Full Information
NCT ID
NCT04310683
First Posted
March 14, 2020
Last Updated
March 14, 2020
Sponsor
Women's Hospital School Of Medicine Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04310683
Brief Title
Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate
Official Title
The Live Birth Rate in Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle in Patients Undergoing Frozen-thawed Embryo Transfer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2020 (Anticipated)
Primary Completion Date
December 10, 2021 (Anticipated)
Study Completion Date
March 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women's Hospital School Of Medicine Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
natural cycle for endometrium preparation
Arm Type
Other
Arm Description
patients will have ovulation before embryo transfer
Arm Title
hormone replaced cycle for endometrium preparation
Arm Type
Experimental
Arm Description
patients will do not have ovulation before embryo transfer
Intervention Type
Other
Intervention Name(s)
natural cycle for endometrium preparation
Other Intervention Name(s)
non
Intervention Description
patients will not use oral contraceptive drugs
Intervention Type
Other
Intervention Name(s)
hormone replaced cycle for endometrium preparation
Other Intervention Name(s)
non
Intervention Description
patients will receive oral contraceptive drugs for menstruation before embryo transfer
Primary Outcome Measure Information:
Title
live birth rate
Description
A delivery is considered successful live birth
Time Frame
delivery
Secondary Outcome Measure Information:
Title
pre-eclampsia
Description
Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)
Time Frame
From gestational week 20 to delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 42 years old women;
normal ovulation;
Scheduled to undergo frozen-thawed embryo transfer.
Agreeing with the informed consent.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Zhang, M.D. Ph.D.
Phone
86-0571-87061501-1008
Email
zhangdan@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Kai-Lun Hu, M.D.
Phone
86-010-15901575271
Email
hukailun@bjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Zhang, M.D. Ph.D.
Organizational Affiliation
Women's Hospital School Of Medicine Zhejiang University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate
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