Infertility, FemaleNCT06005207
Vaginal Progesterone Improves Clinical Outcomes of RIF Patients
A study testing progesterone vaginal sustained-release gel in people with Infertility, Female, run by Nanjing University at 1 site in China.
Trial summary
This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- progesterone vaginal sustained-release gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 31 Dec 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 and 40 years old;
- BMI: 18-28 kg/m2；
- Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:
- Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
- At least 1 high-quality embryo remained for embryo transfer;
- Volunteer to participate in the study and sign the informed consent form.
Who cannot join
- Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
- Adverse pregnancy history (stillbirth, fetal malformation, etc.);
- Severe paternal factors: need for TESA or PESA;
- PGT;
- Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids > 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
- Chromosome abnormality of either spouse;
- Those with contraindications to pregnancy or assisted reproductive technology.
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
Chenyang Huang, +86 25 8310 7188, dianshui19901562@126.com
About this study
Official title: A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure
This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.
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 vaginal progesterone added group (test group). Group B was the regular FET group (control group).
- Conditions
- Infertility, Female
- Being tested
- progesterone vaginal sustained-release gel
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progesterone vaginal sustained-release gelDrug
90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support
| Study group | Role | What they receive |
|---|---|---|
| Vaginal progesterone supplementation | Experimental | 90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support Receives: Drug: progesterone vaginal sustained-release gel |
| Regular progesterone | No intervention | No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (4)
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
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
Persistent pregnancy rate
The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.
Measured: 20 weeks after embryo transfer
Live birth rate
The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.
Measured: 40 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 posted22 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- 152 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
- NCT06005207
- Sponsor's protocol ID
- SZ-RIF-P-2023
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure
- ClinicalTrials.gov ID
- NCT06005207
- Acronym / sponsor ID
- SZ-RIF-P-2023
- Conditions
- Infertility, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Nanjing UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 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.
This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.
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 vaginal progesterone added group (test group). Group B was the regular FET group (control group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal progesterone supplementation | Experimental | Drug: progesterone vaginal sustained-release gel90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support |
| Regular progesterone | No intervention | –No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged between 20 and 40 years old;
- BMI: 18-28 kg/m2；
- Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:
- Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
- At least 1 high-quality embryo remained for embryo transfer;
Key exclusion criteria (7 listed)
- Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
- Adverse pregnancy history (stillbirth, fetal malformation, etc.);
- Severe paternal factors: need for TESA or PESA;
- PGT;
- Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids > 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
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 |
|---|---|---|
| progesterone vaginal sustained-release gel90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support | Drug | Vaginal progesterone supplementation |
Primary outcome
Embryo implantation rate
Time frame: 45 days after embryo transfer
The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
4 secondary outcomes
Clinical pregnancy rate
Time frame: 45 days after embryo transfer
Early pregnancy loss rate
Time frame: 12 weeks after embryo transfer
Persistent pregnancy rate
Time frame: 20 weeks after embryo transfer
Live birth rate
Time frame: 40 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 22 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. 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 progesterone vaginal sustained-release gel in people with Infertility, Female, 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 7 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 22 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chenyang Huang (+862583107188, dianshui19901562@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo implantation 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 22 Aug 2023.