FETNCT05545592
Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer
A study testing Low oestrogen dosage in people with FET, run by Nanjing University at 1 site in China.
Trial summary
This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- FET
- What is being tested?
- Low oestrogen dosage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 Jun 2026
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female;
- Aged between 20 and 40 years old;
- Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
- Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
- The total number of transfer cycles was < 3;
- Volunteer to participate in the study and sign the informed consent.
Who cannot join
- Patients with chromosomal abnormalities;
- Contraindications to hormone replacement therapy;
- Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- Participating in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Jun Xing, +86 25 8310 7188, xing.jun@msn.com
About this study
Official title: A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer
This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.
Read the detailed description
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).
- Conditions
- FET
- Being tested
- Low oestrogen dosage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low oestrogen dosageOther
From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.
| Study group | Role | What they receive |
|---|---|---|
| Low oestrogen | Experimental | The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles Receives: Other: Low oestrogen dosage |
| Regular oestrogen | No intervention | The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.
Measured: 45 days after embryo transfer
Secondary outcomes (6)
Embryo implantation rate
The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
Measured: 45 days after embryo transfer
Early pregnancy loss rate
The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.
Measured: 12 weeks after embryo transfer
Incidence of thrombosis
Thrombosis incidence refers to the proportion of patients with deep venous thrombosis in the total patients.
Measured: 12 weeks after embryo transfer
Incidence rate of gestational hypertension
The incidence rate of gestational hypertension refers to the proportion of patients with gestational hypertension in the total pregnant patients.
Measured: 45 weeks after embryo transfer
Premature birth rate
Preterm birth rate refers to the proportion of patients with preterm birth in all pregnancies.
Measured: 41 weeks after embryo transfer
Proportion of low birth weight infants
The proportion of low birth weight infants refers to the proportion of low birth weight infants in all newborns.
Measured: 41 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FETStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545592
- Sponsor's protocol ID
- SZ-HRT-2022
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT05545592
- Acronym / sponsor ID
- SZ-HRT-2022
- Conditions
- FET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 19 Sep 2022 (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.
This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.
Detailed description
According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low oestrogen | Experimental | Other: Low oestrogen dosageThe patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles |
| Regular oestrogen | No intervention | –The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female;
- Aged between 20 and 40 years old;
- Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);
- Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;
- The total number of transfer cycles was < 3;
Key exclusion criteria (4 listed)
- Patients with chromosomal abnormalities;
- Contraindications to hormone replacement therapy;
- Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;
- Participating in other clinical studies.
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 |
|---|---|---|
| Low oestrogen dosageFrom the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle. | Other | Low oestrogen |
Primary outcome
Clinical pregnancy rate
Time frame: 45 days after embryo transfer
Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.
6 secondary outcomes
Embryo implantation rate
Time frame: 45 days after embryo transfer
Early pregnancy loss rate
Time frame: 12 weeks after embryo transfer
Incidence of thrombosis
Time frame: 12 weeks after embryo transfer
Incidence rate of gestational hypertension
Time frame: 45 weeks after embryo transfer
Premature birth rate
Time frame: 41 weeks after embryo transfer
Proportion of low birth weight infants
Time frame: 41 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low oestrogen dosage in people with FET, run by Nanjing University at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Xing (+862583107188, xing.jun@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancy rate (time frame: 45 days after embryo transfer). 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 19 Sep 2022.