Natural Cycle Versus Hormone Replaced Cycle

NCT04310683 | Withdrawn

• 1 other identifier: PREECLAMPSIA
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: 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 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.

Conditions

IVF

Keywords

natural cycle; hormone replacement cycle; gestational hypertensive disease; frozen cycle

Outcome Measures

Primary Outcomes (1)

• The Gestational hypertension rate

  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 Outcomes (1)

• The pre-eclampsia rate

  From gestational week 20 to delivery

Study Arms (2)

natural cycle for endometrium preparation

EXPERIMENTAL

patients will not receive oral contraceptive drugs for menstruation or drugs for ovulation induction before embryo transfer and patients will ovulate before embryo transfer

Procedure: natural cycle for endometrium preparation

hormone replaced cycle for endometrium preparation

ACTIVE COMPARATOR

patients will receive oral contraceptive drugs for menstruation before embryo transfer and patients will not ovulate before embryo transfer

Procedure: hormone replaced cycle for endometrium preparation

Interventions

natural cycle for endometrium preparation PROCEDURE

patients will not use oral contraceptive drugs

Also known as: natural cycle

natural cycle for endometrium preparation

hormone replaced cycle for endometrium preparation PROCEDURE

patients will receive oral contraceptive drugs for menstruation before embryo transfer

Also known as: hormone replaced cycle

hormone replaced cycle for endometrium preparation

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 45 years old women;
• Scheduled to undergo frozen-thawed embryo transfer.
• Agreeing with the informed consent.

You may not qualify if:

• Hypertention disease before embryo transfer;
• Oocyte or sperm donated cycles
• Recurrent miscarriage (at least two miscarriage history)
• Ovulatory dysfunction

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Officials

• Dan Zhang, M.D. Ph.D.

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

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: December 10, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From January 2022 onwards
• Access Criteria: Data will be shared on reasonable request