IVFNCT04310683
Natural Cycle Versus Hormone Replaced Cycle
A study testing natural cycle for endometrium preparation and hormone replaced cycle for endometrium preparation in people with IVF, run by Women's Hospital School Of Medicine Zhejiang University.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- IVF
- What is being tested?
- natural cycle for endometrium preparation and hormone replaced cycle for endometrium preparation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2020to 10 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20 to 45 years old women;
- Scheduled to undergo frozen-thawed embryo transfer.
- Agreeing with the informed consent.
Who cannot join
- Hypertention disease before embryo transfer;
- Oocyte or sperm donated cycles
- Recurrent miscarriage (at least two miscarriage history)
- Ovulatory dysfunction
About this study
Official title: Natural Cycle Versus Hormone Replaced Cycle in Frozen-thawed Embryo Transfer: a Randomized Controlled Non-inferiority Trial
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.
Read the 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.
- Conditions
- IVF
- Being tested
- natural cycle for endometrium preparation, hormone replaced cycle for endometrium preparation
- Keywords
- natural cycle, hormone replacement cycle, gestational hypertensive disease, frozen cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural cycle for endometrium preparationProcedure or surgery
Also called natural cycle
patients will not use oral contraceptive drugs
hormone replaced cycle for endometrium preparationProcedure or surgery
Also called hormone replaced cycle
patients will receive oral contraceptive drugs for menstruation before embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: hormone replaced cycle for endometrium preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: delivery
Secondary outcomes (1)
The pre-eclampsia rate
Preeclampsia is defined using the current American College of Obstetricians and Gynecologists definitions (Gynecologists; and Pregnancy 2013)
Measured: From gestational week 20 to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start10 Dec 2020
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Zhang, M.D. Ph.D., Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310683
- Sponsor's protocol ID
- PREECLAMPSIA
- Status last verified
- Aug 2026
- First submitted
- 14 Mar 2020
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared on reasonable request once the study has been complete
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural Cycle Versus Hormone Replaced Cycle in Frozen-thawed Embryo Transfer: a Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04310683
- Acronym / sponsor ID
- PREECLAMPSIA
- Conditions
- IVF
- Keywords
- natural cycle, hormone replacement cycle, gestational hypertensive disease, frozen cycle
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural cycle for endometrium preparation | Experimental | Procedure: natural cycle for endometrium preparationpatients will not receive oral contraceptive drugs for menstruation or drugs for ovulation induction before embryo transfer and patients will ovulate before embryo transfer |
| hormone replaced cycle for endometrium preparation | Active comparator | Procedure: hormone replaced cycle for endometrium preparationpatients will receive oral contraceptive drugs for menstruation before embryo transfer and patients will not ovulate before embryo transfer |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20 to 45 years old women;
- Scheduled to undergo frozen-thawed embryo transfer.
- Agreeing with the informed consent.
Key exclusion criteria (4 listed)
- Hypertention disease before embryo transfer;
- Oocyte or sperm donated cycles
- Recurrent miscarriage (at least two miscarriage history)
- Ovulatory dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural cycle for endometrium preparationAlso: natural cyclepatients will not use oral contraceptive drugs | Procedure or surgery | natural cycle for endometrium preparation |
| hormone replaced cycle for endometrium preparationAlso: hormone replaced cyclepatients will receive oral contraceptive drugs for menstruation before embryo transfer | Procedure or surgery | hormone replaced cycle for endometrium preparation |
Primary outcome
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
1 secondary outcome
The pre-eclampsia rate
Time frame: From gestational week 20 to delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. Data will be shared on reasonable request once the study has been complete
Related trials for IVF
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Active, not recruitingPhase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Zhang, M.D. Ph.D. principal investigator
Women's Hospital School Of Medicine Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing natural cycle for endometrium preparation and hormone replaced cycle for endometrium preparation in people with IVF, run by Women's Hospital School Of Medicine Zhejiang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Gestational hypertension rate (time frame: delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.