Natural Cycle Versus Hormone Replaced Cycle
Natural Cycle Versus Hormone Replaced Cycle in Frozen-thawed Embryo Transfer: a Randomized Controlled Non-inferiority Trial
Study Overview
Status
Conditions
Detailed Description
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 controlled non-inferiority trial to compare the live birth rate and gestational hypertention disease rate between the natural cycle and the hormone replaced cycle in women undergoing FET.
The investigators plan to enroll women scheduled for frozen-thawed cycles. Eligible participants will be randomised 1:1 to the natural cycle and the hormone replaced cycle for endometrium preparation. All other IVF procedures will be carried out following a routine method in each center. Women will be followed up until six months after randomisation for those who fail to get pregnant after the completion of the first embryo transfer or delivery for those who get pregnant after the embryo transfer. The primary outcome is live birth after the embryo transfer. Primary analysis will be by intention-to-treat analysis. A 10% live birth is considered to be valid. Considering 10% loss to follow-up with a significance level at 0.05 and a power of 80%, the investigators plan to recruit 960 women to demonstrate women treated with natural cycle have no inferiority regarding live birth rate than those treated with hormone replacement cycle.
Study Type
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 20 to 45 years old women;
- Scheduled to undergo frozen-thawed embryo transfer.
- Agreeing with the informed consent.
Exclusion Criteria:
- Hypertention disease before embryo transfer;
- Oocyte or sperm donated cycles
- Recurrent miscarriage (at least two miscarriage history)
- Ovulatory dysfunction
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: natural cycle for endometrium preparation
patients will not receive oral contraceptive drugs for menstruation or drugs for ovulation induction before embryo transfer and patients will ovulate before embryo transfer
|
patients will not use oral contraceptive drugs
Other Names:
|
|
Active Comparator: hormone replaced cycle for endometrium preparation
patients will receive oral contraceptive drugs for menstruation before embryo transfer and patients will not ovulate before embryo transfer
|
patients will receive oral contraceptive drugs for menstruation before embryo transfer
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Gestational hypertension rate
Time Frame: delivery
|
defined with blood pressure over 140/90 mmhg from gestational week 20 to delivery with or without other complications by the enrolled patients
|
delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The pre-eclampsia rate
Time Frame: From gestational week 20 to delivery
|
Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)
|
From gestational week 20 to delivery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Dan Zhang, M.D. Ph.D., Women's Hospital School Of Medicine Zhejiang University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PREECLAMPSIA (Al-Ahliyya Amman University)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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