PCOS (Polycystic Ovary Syndrome)FMT-PMOSNCT07746635
Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome
A study testing oral Fecal Microbiota Transplantation in people with PCOS (Polycystic Ovary Syndrome), run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- oral Fecal Microbiota Transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to 31 Dec 2028
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 1. Females aged 20 to 40 years old.
- 2. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).
- 3. Body Mass Index (BMI): >24.0 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24.0 kg/m² upwards).
- 4. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.
- 5. Voluntary participation with signed Informed Consent Form (ICF).
Who cannot join
- Age < 20 or > 40 years.
- Pregnancy or lactation.
- Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.
- Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.
- Concurrent participation in other clinical trials.
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
Center for Reproductive Medicine,Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Jiping Xu, 021-81886702, zorzhang@163.com
Yichi Zhang, zorzhang@163.com
About this study
Official title: Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial
This prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases:
Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.
Phase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
Read the detailed description
Background:Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly recognized as Polycystic Ovary Syndrome (PCOS), is a systemic disorder characterized by hyperandrogenism, insulin resistance, chronic low-grade inflammation, and gut microbiota dysbiosis. These abnormalities frequently impair endometrial receptivity, oocyte quality, and clinical pregnancy outcomes in assisted reproductive technology (ART) cycles. Fecal Microbiota Transplantation (FMT) offers a targeted approach to restore gut microecology and alleviate metabolic-endocrine dysfunction.
Study Design:This study adopts a prospective, two-stage sequential implementation framework.
Phase 1 (Single-Arm Exploratory Pilot Stage):
Objective: To establish preliminary safety, tolerability, gut microbiota remodeling, and reproductive feasibility of oral FMT in PMOS patients undergoing FET.
Cohort: An initial exploratory cohort of 11 evaluable overweight or obese patients with PMOS (BMI≥24.0kg/m2) scheduled for Frozen-Thawed Embryo Transfer (FET).
Design: Prospective, open-label, single-arm pilot study without a concurrent control group.
Phase 2 (Randomized Controlled Trial Stage):
Objective: To rigorously confirm therapeutic efficacy, metabolic amelioration, and pregnancy rate enhancement in a larger sample size based on Phase 1 safety and biomarker findings.
Design: Prospective, randomized controlled trial comparing oral FMT capsule intervention with standard care/placebo control.
Intervention Protocol:Participants in the FMT intervention receive oral FMT freeze-dried powder capsules derived from strictly screened, traceable healthy donors provided by a standardized Microbiota Biobank.
Dosage: 5 capsules twice daily, taken orally on an empty stomach for 6 consecutive days per course.
Schedule: Three identical courses separated by a 4-week interval. Background Care: Standardized lifestyle and dietary guidance are maintained throughout both phases.
Study Endpoints:
Primary Endpoints:Reproductive and pregnancy outcomes following FET (biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate).Safety and tolerability (incidence, severity, and causality of Adverse Events).
Secondary Endpoints:
Endocrine profiles (LH, FSH, Total Testosterone, Free Testosterone, PRL, Progesterone, Estradiol).
Metabolic and glycemic parameters (BMI, fasting blood glucose, HbA1c, fasting insulin, HOMA-IR, lipid profiles).
Systemic inflammatory and gut barrier markers (CRP, TNF-α, IL-6, IL-22, LPS). Gut microbiota structure and diversity via metagenomic sequencing and bile acid metabolomics.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- oral Fecal Microbiota Transplantation, Placebo
- Keywords
- FMT, PCOS, PMOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral Fecal Microbiota TransplantationBiological
Participants will receive standardized oral FMT freeze-dried powder capsules without antibiotic pretreatment. The capsules are derived from strictly screened, traceable healthy donors from a standardized Microbiota Biobank.
Dosage and Regimen: Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days, which constitutes one course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8.
Background: Standardized lifestyle and dietary guidance will be provided throughout the study.
PlaceboOther
Participants will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment.
Dosage and Regimen:Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days per course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8, exactly mirroring the experimental arm.
Background: Standardized lifestyle and dietary guidance will be provided throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Oral FMT Capsules Group | Experimental | Participants in this experimental arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive standardized oral fecal microbiota transplantation (FMT) capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study. Receives: Biological: oral Fecal Microbiota Transplantation |
| Placebo Capsules Group | Placebo comparator | Participants in this comparing arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
The percentage of participants who achieve a confirmed clinical pregnancy, defined as the presence of at least one intrauterine gestational sac with a viable fetal heartbeat confirmed by transvaginal ultrasound.
Measured: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).
Biochemical Pregnancy Rate
The percentage of participants who achieve a biochemical pregnancy, confirmed by a serum beta-hCG level > 10 mIU/mL.
Measured: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)
Incidence of Adverse Events (AEs)
The number of participants experiencing any treatment-related adverse events or serious adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0),including diarrhea,bloating,abdominal pain,constipation,etc.
Measured: Assessed from the first dose of FMT through the 12-week post-treatment follow-up
Secondary outcomes (7)
Change in Body Mass Index (BMI)
Evaluation of the mean change in Body Mass Index (calculated as weight in kilograms divided by height in meters squared) from baseline to post-treatment.
Measured: Baseline and 4 weeks post-FMT.
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Evaluation of the mean change in insulin resistance assessed by the HOMA-IR index (calculated from fasting blood glucose and fasting insulin levels).
Measured: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Total Testosterone (T) Level
Evaluation of the mean change in fasting serum total testosterone levels from baseline.
Measured: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Luteinizing Hormone (LH) Level
Evaluation of the mean change in fasting serum luteinizing hormone levels from baseline.
Measured: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Interleukin-6 (IL-6) Level
Evaluation of the mean change in systemic inflammatory marker Interleukin-6 (IL-6) from baseline.
Measured: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Gut Microbiota Alpha Diversity (Shannon Index)
Evaluation of the change in gut microbial alpha diversity from baseline, primarily assessed using the Shannon Diversity Index derived from metagenomic or 16S rRNA sequencing of fecal samples.
Measured: Baseline and 4 weeks post-FMT.
Live Birth Rate (LBR)
The percentage of participants who deliver at least one live-born infant after 24 weeks of gestation.
Measured: Assesssed up to 42 weeks following the Frozen-Thawed Embryo Transfer (FET)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start15 Apr 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe sponsor's other registered studies.
- 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
- Model description
- Phase 1: Single Group Assignment Phase 2: Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ningxia Sun, Shanghai Changzheng Hospital
- Investigators
- Ningxia Sun, MD-PhD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746635
- Sponsor's protocol ID
- 2025SL038
- Acronym
- FMT-PMOS
- Status last verified
- Sep 2026
- First submitted
- 25 Jul 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07746635
- Acronym / sponsor ID
- FMT-PMOS / 2025SL038
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Keywords
- FMT, PCOS, PMOS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 201 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2026 (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 prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases:
Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.
Phase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.
Detailed description
Background:Polyendocrine Metabolic Ovarian Syndrome (PMOS), formerly recognized as Polycystic Ovary Syndrome (PCOS), is a systemic disorder characterized by hyperandrogenism, insulin resistance, chronic low-grade inflammation, and gut microbiota dysbiosis. These abnormalities frequently impair endometrial receptivity, oocyte quality, and clinical pregnancy outcomes in assisted reproductive technology (ART) cycles. Fecal Microbiota Transplantation (FMT) offers a targeted approach to restore gut microecology and alleviate metabolic-endocrine dysfunction.
Study Design:This study adopts a prospective, two-stage sequential implementation framework.
Phase 1 (Single-Arm Exploratory Pilot Stage):
Objective: To establish preliminary safety, tolerability, gut microbiota remodeling, and reproductive feasibility of oral FMT in PMOS patients undergoing FET.
Cohort: An initial exploratory cohort of 11 evaluable overweight or obese patients with PMOS (BMI≥24.0kg/m2) scheduled for Frozen-Thawed Embryo Transfer (FET).
Design: Prospective, open-label, single-arm pilot study without a concurrent control group.
Phase 2 (Randomized Controlled Trial Stage):
Objective: To rigorously confirm therapeutic efficacy, metabolic amelioration, and pregnancy rate enhancement in a larger sample size based on Phase 1 safety and biomarker findings.
Design: Prospective, randomized controlled trial comparing oral FMT capsule intervention with standard care/placebo control.
Intervention Protocol:Participants in the FMT intervention receive oral FMT freeze-dried powder capsules derived from strictly screened, traceable healthy donors provided by a standardized Microbiota Biobank.
Dosage: 5 capsules twice daily, taken orally on an empty stomach for 6 consecutive days per course.
Schedule: Three identical courses separated by a 4-week interval. Background Care: Standardized lifestyle and dietary guidance are maintained throughout both phases.
Study Endpoints:
Primary Endpoints:Reproductive and pregnancy outcomes following FET (biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate).Safety and tolerability (incidence, severity, and causality of Adverse Events).
Secondary Endpoints:
Endocrine profiles (LH, FSH, Total Testosterone, Free Testosterone, PRL, Progesterone, Estradiol).
Metabolic and glycemic parameters (BMI, fasting blood glucose, HbA1c, fasting insulin, HOMA-IR, lipid profiles).
Systemic inflammatory and gut barrier markers (CRP, TNF-α, IL-6, IL-22, LPS). Gut microbiota structure and diversity via metagenomic sequencing and bile acid metabolomics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase 1: Single Group Assignment Phase 2: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Oral FMT Capsules Group | Experimental | Biological: oral Fecal Microbiota TransplantationParticipants in this experimental arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive standardized oral fecal microbiota transplantation (FMT) capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study. |
| Placebo Capsules Group | Placebo comparator | Other: PlaceboParticipants in this comparing arm are overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) scheduled for Frozen-Thawed Embryo Transfer (FET). They will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Standardized lifestyle and dietary guidance will be provided throughout the study. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1. Females aged 20 to 40 years old.
- 2. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).
- 3. Body Mass Index (BMI): >24.0 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24.0 kg/m² upwards).
- 4. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.
- 5. Voluntary participation with signed Informed Consent Form (ICF).
Key exclusion criteria (5 listed)
- Age < 20 or > 40 years.
- Pregnancy or lactation.
- Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.
- Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.
- Concurrent participation in other clinical trials.
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 |
|---|---|---|
| oral Fecal Microbiota TransplantationParticipants will receive standardized oral FMT freeze-dried powder capsules without antibiotic pretreatment. The capsules are derived from strictly screened, traceable healthy donors from a standardized Microbiota Biobank. Dosage and Regimen: Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days, which constitutes one course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8. Background: Standardized lifestyle and dietary guidance will be provided throughout the study. | Biological | Oral FMT Capsules Group |
| PlaceboParticipants will receive visually and olfactory-matched placebo capsules without antibiotic pretreatment. Dosage and Regimen:Oral administration of 5 capsules twice daily on an empty stomach for 6 consecutive days per course. The complete regimen consists of 3 identical courses administered at Week 0, Week 4, and Week 8, exactly mirroring the experimental arm. Background: Standardized lifestyle and dietary guidance will be provided throughout the study. | Other | Placebo Capsules Group |
Primary outcome
Clinical Pregnancy Rate
Time frame: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).
The percentage of participants who achieve a confirmed clinical pregnancy, defined as the presence of at least one intrauterine gestational sac with a viable fetal heartbeat confirmed by transvaginal ultrasound.
Biochemical Pregnancy Rate
Time frame: Assessed at 14 days following the Frozen-Thawed Embryo Transfer (FET)
The percentage of participants who achieve a biochemical pregnancy, confirmed by a serum beta-hCG level > 10 mIU/mL.
Incidence of Adverse Events (AEs)
Time frame: Assessed from the first dose of FMT through the 12-week post-treatment follow-up
The number of participants experiencing any treatment-related adverse events or serious adverse events, graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0),including diarrhea,bloating,abdominal pain,constipation,etc.
7 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and 4 weeks post-FMT.
Change in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Total Testosterone (T) Level
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Luteinizing Hormone (LH) Level
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Serum Interleukin-6 (IL-6) Level
Time frame: Baseline, 4 weeks post-FMT, and 12 weeks post-FMT.
Change in Gut Microbiota Alpha Diversity (Shannon Index)
Time frame: Baseline and 4 weeks post-FMT.
Live Birth Rate (LBR)
Time frame: Assesssed up to 42 weeks following the Frozen-Thawed Embryo Transfer (FET)
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 22 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ningxia Sun, MD-PhD principal investigator
Shanghai Changzheng 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 oral Fecal Microbiota Transplantation in people with PCOS (Polycystic Ovary Syndrome), run by Shanghai Changzheng 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 5 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. 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?
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 Ningxia Sun, Chief (13817975897, suesunchzh@126.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: Assessed up to 8 weeks following the Frozen-Thawed Embryo Transfer (FET)(approximately within 6 months following the completion of the FMT intervention).). The study lists 3 primary outcomes in all. 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 Sep 2026.