Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle for Pre-eclampsia Rate

March 14, 2020 updated by: Women's Hospital School Of Medicine Zhejiang University

The Live Birth Rate in Natural Cycle or Stimulated Cycle Versus Hormone Replaced Cycle in Patients Undergoing Frozen-thawed Embryo Transfer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 18 to 42 years old women;
  2. normal ovulation;
  3. Scheduled to undergo frozen-thawed embryo transfer.
  4. Agreeing with the informed consent.

Exclusion Criteria:

  1. Those who experienced embryo transfer cycle failure for at least three times;
  2. One or both of the ovaries removed;
  3. Hypertention disease before embryo transfer;
  4. No available embryo for transfer
  5. Oocyte or sperm donated cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: natural cycle for endometrium preparation
patients will have ovulation before embryo transfer
Other: natural cycle for endometrium preparation
patients will not use oral contraceptive drugs
Other Names:
  • non
Experimental: hormone replaced cycle for endometrium preparation
patients will do not have ovulation before embryo transfer
Other: hormone replaced cycle for endometrium preparation
patients will receive oral contraceptive drugs for menstruation before embryo transfer
Other Names:
  • non

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: delivery
A delivery is considered successful live birth
delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-eclampsia
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

This is where you will find people and organizations involved with this study.

Sponsor

Women's Hospital School Of Medicine Zhejiang University

Investigators

  • Principal Investigator: Dan Zhang, M.D. Ph.D., Women's Hospital School of Medicine Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2020

Primary Completion (Anticipated)

December 10, 2021

Study Completion (Anticipated)

March 10, 2022

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREECLAMPSIA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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