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

Pre-Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04310683
• Other study ID #: PREECLAMPSIA
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2020
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Dan Zhang, M.D. Ph.D.
• Phone: 86-0571-87061501-1008
• Email: zhangdan[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 840
• Est. completion date: March 10, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Pre-Eclampsia

Intervention

Other:
• natural cycle for endometrium preparation
patients will not use oral contraceptive drugs
• hormone replaced cycle for endometrium preparation
patients will receive oral contraceptive drugs for menstruation before embryo transfer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	A delivery is considered successful live birth	delivery
Secondary	pre-eclampsia	Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)	From gestational week 20 to delivery