Thin EndometriumNCT04292886
Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
A study testing Tamoxifen and femoston and Vitamin C and femoston in people with Thin Endometrium, run by Nanjing University at 1 site in China.
Trial summary
The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Thin Endometrium
- What is being tested?
- Tamoxifen and femoston and Vitamin C and femoston
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 30 Nov 2021
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1) Younger than 38 years old, basal serum level of follicle stimulating hormone <10 IU / L; (2) Endometrium is less than 8mm in at least 2 cycles: superovulation cycle / natural cycle / estrogen replacement therapy / ovarian stimulation cycle; (3) at least 1 high quality frozen embryo; (4) There are no comorbidities that clearly affect pregnancy, such as adenomyosis, endometriosis, and intrauterine adhesions;
Who cannot join
- abnormal karyotype;
- Accompanying other diseases of the uterus: uterine muscular wall myomas that affect the uterine cavity shape, more severe adenomyosis, severe endometriosis, congenital uterine malformations, endometrial tuberculosis, etc .;
- Contraindications to hormone replacement therapy;
- Participating in other clinical research;
- History of previous fundus diseases;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Qingqing Shi, Ph.D, qqshnju@sina.com
About this study
Official title: Hormone Replacement Versus Tamoxifen Combined Of Hormone Replacement in Women With a Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy between hormone replacement and Tamoxifen combined Of hormone replacement.This is a prospective, randomized placebo-controlled, double-blind clinical trial that includes 120 patients younger than 38 years old with a thin endometrium preparing for frozen embryo transfer. Participants will be randomly assigned (1: 1) into two parallel groups: estrogen replacement and tamoxifen combined with estrogen replacement.Frozen embryo resuscitation transfer cycle for thin endometrium patients。This is the first randomized controlled trial to comparing estrogen and estrogen combined with tamoxifen for endometrial improvement，The results of this study will provide evidence for the efficacy of the strategy of frozen embryo transfer cycle for thin endometrium patients.
- Conditions
- Thin Endometrium
- Being tested
- Tamoxifen and femoston, Vitamin C and femoston
- Keywords
- thin endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamoxifen and femostonDrug
oral
Vitamin C and femostonDrug
Vitamin C and femoston
| Study group | Role | What they receive |
|---|---|---|
| thin endometrium ,treatment,Tamoxifen | Active comparator | From the 2nd day of the menstrual cycle, the patient took tamoxifen and femoston Receives: Drug: Tamoxifen and femoston |
| thin endometrium ,treatment,Vitamin C | Placebo comparator | From the 2nd day of the menstrual cycle, the patient took Vitamin C and femoston Receives: Drug: Vitamin C and femoston |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness
Endometrial thickness were record using transvaginal ultrasound scan.
Measured: within the 15 days (plus or minus 5 days) after oral drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Oct 2019
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thin EndometriumStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-jun Ding, Nanjing University
- Investigators
- Haixiang Sun, Ph.D, Principal investigator, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292886
- Sponsor's protocol ID
- NanjingU
- Status last verified
- Mar 2020
- First submitted
- 1 Mar 2020
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi Q, Mei J, Yan G, Kong N, Liu J, Shen X, Sun Y, Lu F, Jiang Y, Sun H, Huang C. Tamoxifen Combined with Hormone Replacement in Women with Thin Endometrium Receiving Frozen-Thawed Embryo Transfer for Promoting Endometrial Growth: A Double-Blinded, Randomized Controlled Trial. Int J Gen Med. 2026 May 13;19:587828. doi: 10.2147/IJGM.S587828. eCollection 2026.
PubMed 42153152
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormone Replacement Versus Tamoxifen Combined Of Hormone Replacement in Women With a Thin Endometrium Undergoing Frozen-thawed Embryo Transfer
- ClinicalTrials.gov ID
- NCT04292886
- Acronym / sponsor ID
- NanjingU
- Conditions
- Thin Endometrium
- Keywords
- thin endometrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 3 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.
The endometrium is essential for embryo implantation. The clinical pregnancy rate and live birth rate of patients with thin endometrium are significantly lower than those of normal endometrium. Previous studies have shown that tamoxifen has advantages for improving endometrial thickness. However, there is still a lack of evidence from randomized clinical trials comparing the efficacy between hormone replacement and Tamoxifen combined Of hormone replacement.This is a prospective, randomized placebo-controlled, double-blind clinical trial that includes 120 patients younger than 38 years old with a thin endometrium preparing for frozen embryo transfer. Participants will be randomly assigned (1: 1) into two parallel groups: estrogen replacement and tamoxifen combined with estrogen replacement.Frozen embryo resuscitation transfer cycle for thin endometrium patients。This is the first randomized controlled trial to comparing estrogen and estrogen combined with tamoxifen for endometrial improvement，The results of this study will provide evidence for the efficacy of the strategy of frozen embryo transfer cycle for thin endometrium patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thin endometrium ,treatment,Tamoxifen | Active comparator | Drug: Tamoxifen and femostonFrom the 2nd day of the menstrual cycle, the patient took tamoxifen and femoston |
| thin endometrium ,treatment,Vitamin C | Placebo comparator | Drug: Vitamin C and femostonFrom the 2nd day of the menstrual cycle, the patient took Vitamin C and femoston |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) Younger than 38 years old, basal serum level of follicle stimulating hormone <10 IU / L; (2) Endometrium is less than 8mm in at least 2 cycles: superovulation cycle / natural cycle / estrogen replacement therapy / ovarian stimulation cycle; (3) at least 1 high quality frozen embryo; (4) There are no comorbidities that clearly affect pregnancy, such as adenomyosis, endometriosis, and intrauterine adhesions;
Key exclusion criteria (5 listed)
- abnormal karyotype;
- Accompanying other diseases of the uterus: uterine muscular wall myomas that affect the uterine cavity shape, more severe adenomyosis, severe endometriosis, congenital uterine malformations, endometrial tuberculosis, etc .;
- Contraindications to hormone replacement therapy;
- Participating in other clinical research;
- History of previous fundus diseases;
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 |
|---|---|---|
| Tamoxifen and femostonoral | Drug | thin endometrium ,treatment,Tamoxifen |
| Vitamin C and femostonVitamin C and femoston | Drug | thin endometrium ,treatment,Vitamin C |
Primary outcome
Endometrial thickness
Time frame: within the 15 days (plus or minus 5 days) after oral drugs
Endometrial thickness were record using transvaginal ultrasound scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Derived from this study: PubMed 42153152Shi Q, Mei J, Yan G, Kong N, Liu J, Shen X, Sun Y, Lu F, Jiang Y, Sun H, Huang C. Tamoxifen Combined with Hormone Replacement in Women with Thin Endometrium Receiving Frozen-Thawed Embryo Transfer for Promoting Endometrial Growth: A Double-Blinded, Randomized Controlled Trial. Int J Gen Med. 2026 May 13;19:587828. doi: 10.2147/IJGM.S587828. eCollection 2026.
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Asherman Syndrome
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Intrauterine G-CSF Infusion for Thin Endometrium
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A Randomized Controlled Study on the Effect of MRJPs on Improving Ovarian Function and Endometrial Receptivity
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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.
Haixiang Sun, Ph.D principal investigator
Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamoxifen and femoston and Vitamin C and femoston in people with Thin Endometrium, 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 1 inclusion and 5 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 3 Mar 2020. 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. Some participants in this study may receive a placebo. 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 Qingqing Shi, Ph.D (15996312878, qqshnju@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrial thickness (time frame: within the 15 days (plus or minus 5 days) after oral drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292886, which also lists 1 linked publication.
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 3 Mar 2020.