LetrozoleNCT06006091
The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)
A study testing Letrozole in people with Letrozole and Infertility, Female, run by International Peace Maternity and Child Health Hospital at 1 site in China.
Trial summary
The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Letrozole, Infertility, Female
- What is being tested?
- Letrozole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 858 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.
Who cannot join
- Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
- patients who underwent pre-implantation genetic diagnosis (PGT);
- patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
- patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2;
- patients with recurrent spontaneous abortions;
- patients with sequential embryo transfer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yu Xiao
Shanghai
Yu Xiao, Dr., ethanhsiao@126.com
About this study
Official title: Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study
The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol.
The main questions it aims to answer are:
Read more
- To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate.
- To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic.
The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (<25 d or >35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.
- Conditions
- Letrozole, Infertility, Female
- Being tested
- Letrozole
- Keywords
- Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Different endothelial preparations according to groups, see arm descriptions for details
| Study group | Role | What they receive |
|---|---|---|
| Letrozole-induced endometrial preparation protocol | Experimental | Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer. Receives: Drug: Letrozole |
| Natural cycles endometrial preparation protocol | No intervention | Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was <7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation. |
| Hormone replacement cycles endometrial preparation protocol | No intervention | Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was <7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
The number of deliveries resulting in at least one live birth
Measured: 40-42 weeks'estimated gestational age
Secondary outcomes (2)
Clinical pregnancy
Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
Measured: 5-7 weeks' estimated gestational age
embryo implantation
Serum Human Chorionic Gonadotropin levels >10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred
Measured: 14 day 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 posted23 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LetrozoleStudies 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
- 858 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Peace Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chenliang Zhou, International Peace Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006091
- Sponsor's protocol ID
- InternationalPMCHH-1
- Status last verified
- Aug 2023
- First submitted
- 31 Jul 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06006091
- Acronym / sponsor ID
- InternationalPMCHH-1
- Conditions
- Letrozole, Infertility, Female
- Keywords
- Frozen-thawed embryo transfer, Letroziole, Endothelial preparation protocol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 858 participants (estimated)
- Lead sponsor
- International Peace Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 23 Aug 2023 (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.
The goal of this single center, non-blinded, randomized controlled clinical trial to comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus natural cycles, hormone replacement protocol.
The main questions it aims to answer are:
- To investigate whether letrozole-induce endothelial preparation is effective in improving the live birth rate and clinical pregnancy rate.
- To explore its possible impact on clinically important indicators such as spontaneous abortion rate, implantation cycle cancellation rate, days of endothelial preparation, and number of visits to the clinic.
The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The study subjects were stratified according to whether their menstrual cycles were regular or not, and were divided into the following endothelial preparation regimens according to the pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35 d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and (2) irregular menstrual cycles (<25 d or >35 d): letrozole ovulation-promoting cycles, hormone-replacement cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Letrozole-induced endometrial preparation protocol | Experimental | Drug: LetrozoleStarting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer. |
| Natural cycles endometrial preparation protocol | No intervention | –Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was <7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation. |
| Hormone replacement cycles endometrial preparation protocol | No intervention | –Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was <7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Women <40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3 superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved. Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per study subject was enrolled.
Key exclusion criteria (6 listed)
- Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as uterine malformations, endometrial polyps, and uterine adhesions;
- patients who underwent pre-implantation genetic diagnosis (PGT);
- patients who underwent ICSI using surgically obtained epididymal or testicular spermatozoa;
- patients with a Body mass index (BMI, = weight/height2 ) > 30 kg/m2;
- patients with recurrent spontaneous abortions;
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 |
|---|---|---|
| LetrozoleDifferent endothelial preparations according to groups, see arm descriptions for details | Drug | Letrozole-induced endometrial preparation protocol |
Primary outcome
Live birth
Time frame: 40-42 weeks'estimated gestational age
The number of deliveries resulting in at least one live birth
2 secondary outcomes
Clinical pregnancy
Time frame: 5-7 weeks' estimated gestational age
embryo implantation
Time frame: 14 day after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole in people with Letrozole and Infertility, Female, run by International Peace Maternity and Child Health Hospital 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Aug 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengliang Zhou, Dr. (08613758240793, chengliang_zhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: 40-42 weeks'estimated gestational age). 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 23 Aug 2023.