Deep Infiltrating Endometriosis (DIE)Phase 4DIE-GnRHa-FETNCT07696351
Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis
A Phase 4 study testing Triptorelin (GnRH agonists) and Hormone Replacement Therapy (HRT) in people with Deep Infiltrating Endometriosis (DIE) and Infertility, run by Li-jun Ding at 1 site in China.
Trial summary
Deep infiltrating endometriosis is a severe form of endometriosis that may reduce fertility and negatively affect pregnancy outcomes after assisted reproductive treatment. Gonadotropin-releasing hormone agonist pretreatment may suppress endometriotic lesions, reduce inflammation, and improve endometrial receptivity… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Deep Infiltrating Endometriosis (DIE), Infertility
- What is being tested?
- Triptorelin (GnRH agonists) and Hormone Replacement Therapy (HRT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 31 Jul 2027
- Phase
- Phase 4
- 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 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18 to 39 years.
- Diagnosed with deep infiltrating endometriosis by ultrasound at the study center.
- Undergoing the first frozen-thawed embryo transfer cycle with hormone replacement therapy for endometrial preparation.
- Having at least one good-quality frozen embryo.
- Willing to participate in this randomized controlled study of GnRH-a pretreatment for deep infiltrating endometriosis and able to personally sign the written informed consent form.
Who cannot join
- Abnormal chromosomal karyotype.
- Other uterine diseases or conditions that may affect uterine cavity morphology or pregnancy outcomes, including intrauterine adhesions affecting the uterine cavity, intramural uterine fibroids, moderate to severe adenomyosis, congenital uterine malformation, endometrial tuberculosis, or endometrial thickness less than 8 mm on the transformation day.
- Recurrent implantation failure.
- Contraindications to hormone replacement therapy or long-acting GnRH-a treatment.
- Osteoporosis or depressed mood.
- Currently participating in another clinical study.
- Unable to adhere to study visits and follow-up, or planning to receive other treatment during the follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yuan Yan contact
China1 site, 1 recruiting
- Recruiting
The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 216000
Jie Mei, PhD, +86 15051839536 Email, meijie560@163.com
Yuan Yan, +86 15950526117
About this study
Official title: A Randomized Controlled Study of Ultra-Long GnRH-a Pretreatment to Improve Frozen-Thawed Embryo Transfer Outcomes in Patients With Deep Infiltrating Endometriosis
Deep infiltrating endometriosis is a severe form of endometriosis that may reduce fertility and negatively affect pregnancy outcomes after assisted reproductive treatment. Gonadotropin-releasing hormone agonist pretreatment may suppress endometriotic lesions, reduce inflammation, and improve endometrial receptivity, but its benefit before frozen-thawed embryo transfer remains uncertain.
This randomized controlled study will evaluate whether ultra-long GnRH-a pretreatment before hormone replacement therapy improves clinical pregnancy outcomes in patients with deep infiltrating endometriosis undergoing their first frozen-thawed embryo transfer cycle. Eligible participants will be randomly assigned to either the GnRH-a pretreatment group or the control group. Participants in the GnRH-a group will receive two injections of long-acting GnRH-a before hormone replacement therapy for endometrial preparation, while participants in the control group will receive routine hormone replacement therapy alone.
The primary outcome is clinical pregnancy rate, defined as the presence of a gestational sac on transvaginal ultrasound 30 ± 3 days after embryo transfer. Secondary outcomes include implantation rate, ectopic pregnancy rate, early spontaneous abortion rate, ongoing pregnancy rate at 12 weeks of gestation, and delivery rate. Safety will be evaluated by recording adverse events after GnRH-a injection. The planned enrollment is 120 participants.
Read the detailed description
Deep infiltrating endometriosis is a severe subtype of endometriosis that may involve pelvic organs and is associated with infertility, impaired endometrial receptivity, chronic pelvic inflammation, reduced implantation, increased miscarriage risk, and poorer outcomes after assisted reproductive treatment. For patients with deep infiltrating endometriosis who require frozen-thawed embryo transfer, the optimal endometrial preparation strategy remains uncertain.
Gonadotropin-releasing hormone agonists may suppress ovarian estrogen production, inhibit the activity of endometriotic lesions, reduce inflammatory mediators, and potentially improve the endometrial environment before embryo transfer. However, current evidence regarding GnRH-a pretreatment before frozen-thawed embryo transfer in patients with endometriosis is inconsistent, and high-quality prospective randomized controlled studies are limited. This study is designed to evaluate whether ultra-long GnRH-a pretreatment improves pregnancy outcomes in patients with deep infiltrating endometriosis undergoing frozen-thawed embryo transfer.
This is a prospective, randomized, controlled, single-center clinical study. A total of 120 eligible participants will be enrolled. Participants must be younger than 40 years, diagnosed with deep infiltrating endometriosis by ultrasound at the study center, undergoing their first frozen-thawed embryo transfer cycle with hormone replacement therapy for endometrial preparation, and have at least one good-quality frozen embryo. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in the experimental group will receive ultra-long GnRH-a pretreatment before frozen-thawed embryo transfer. Long-acting GnRH-a will be administered on menstrual cycle days 2 to 4, followed by a second injection 28 to 30 days later. Hormone replacement therapy for endometrial preparation will begin 28 to 30 days after the second GnRH-a injection, followed by frozen-thawed embryo transfer according to routine clinical practice.
Participants in the control group will undergo routine hormone replacement therapy for endometrial preparation before frozen-thawed embryo transfer without GnRH-a pretreatment.
The primary outcome is clinical pregnancy rate, defined as the presence of a gestational sac detected by transvaginal ultrasound 30 ± 3 days after embryo transfer. Secondary outcomes include implantation rate, ectopic pregnancy rate, early spontaneous abortion rate, ongoing pregnancy rate at 12 weeks of gestation, and delivery rate. Additional pregnancy, obstetric, and neonatal outcomes may be followed according to the study protocol, including biochemical pregnancy, late spontaneous abortion, preterm birth, stillbirth, live birth, pregnancy complications, delivery outcomes, and birth weight.
Safety will be assessed by monitoring and recording adverse events after GnRH-a injection, including hot flashes, headache, sleep disturbance, vaginal bleeding or spotting, night sweats, and mood changes. Participants will be followed after embryo transfer and, if pregnancy occurs, through pregnancy and delivery according to the protocol-defined follow-up schedule.
- Conditions
- Deep Infiltrating Endometriosis (DIE), Infertility
- Being tested
- Triptorelin (GnRH agonists), Hormone Replacement Therapy (HRT)
- Keywords
- Deep infiltrating endometriosis, GnRH-a, Triptorelin, Frozen-thawed embryo transfer, Hormone replacement therapy, Clinical pregnancy rate, Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin (GnRH agonists)Drug
Also called GnRHa
Long-acting GnRH-a pretreatment will be administered before hormone replacement therapy for endometrial preparation. Participants will receive two injections of triptorelin 3.75 mg: the first on menstrual cycle days 2 to 4 and the second 28 to 30 days later.
Hormone Replacement Therapy (HRT)Other
Also called HRT
Routine hormone replacement therapy will be used for endometrial preparation before frozen-thawed embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-Long GnRH-a Pretreatment Group | Experimental | Participants in this group will receive ultra-long GnRH-a pretreatment before frozen-thawed embryo transfer. Long-acting GnRH-a will be administered on menstrual cycle days 2 to 4, followed by a second injection 28 to 30 days later. Hormone replacement therapy for endometrial preparation will begin 28 to 30 days after the second GnRH-a injection, followed by frozen-thawed embryo transfer according to routine clinical practice. Receives: Drug: Triptorelin (GnRH agonists) |
| Routine HRT Group | Active comparator | Participants in this group will undergo routine hormone replacement therapy for endometrial preparation before frozen-thawed embryo transfer without GnRH-a pretreatment. Receives: Other: Hormone Replacement Therapy (HRT) |
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 a gestational sac detected by transvaginal ultrasound 30 ± 3 days after embryo transfer. Clinical pregnancy rate will be calculated as the number of clinical pregnancy cycles divided by the total number of embryo transfer cycles.
Measured: 30 ± 3 days after embryo transfer
Secondary outcomes (5)
Implantation Rate
Implantation rate will be calculated based on the number of gestational sacs observed by ultrasound relative to the number of embryos transferred.
Measured: 30 ± 3 days after embryo transfer
Ectopic Pregnancy Rate
Ectopic pregnancy rate will be calculated as the number of ectopic pregnancy cases divided by the total number of embryo transfer cycles.
Measured: Up to 49 ± 7 days after embryo transfer
Early Spontaneous Abortion Rate
Early spontaneous abortion rate will be calculated as the number of early spontaneous abortions divided by the number of clinical pregnancy cycles.
Measured: Up to 12 weeks of gestation
Ongoing Pregnancy Rate at 12 Weeks of Gestation
Ongoing pregnancy rate will be calculated as the number of participants with ongoing pregnancy at 12 weeks of gestation divided by the total number of embryo transfer cycles.
Measured: 12 weeks of gestation
Delivery Rate
Delivery rate will be calculated as the number of participants who deliver divided by the total number of embryo transfer cycles.
Measured: At delivery, up to study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Aug 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Deep Infiltrating Endometriosis (DIE)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the ultra-long GnRH-a pretreatment group or the routine hormone replacement therapy control group. The two groups will be compared in parallel to evaluate the effect of GnRH-a pretreatment on frozen-thawed embryo transfer outcomes.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li-jun Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li-jun Ding, Nanjing University
- Investigators
- Jie Mei, Principal investigator, Department of Reproductive Medicine, Nanjing Drum Tower Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696351
- Sponsor's protocol ID
- DIE-GnRHa-FET-RCT-2025-01
- Other IDs
- 2025-0564
- Acronym
- DIE-GnRHa-FET
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Surrey ES, Katz-Jaffe M, Kondapalli LV, Gustofson RL, Schoolcraft WB. GnRH agonist administration prior to embryo transfer in freeze-all cycles of patients with endometriosis or aberrant endometrial integrin expression. Reprod Biomed Online. 2017 Aug;35(2):145-151. doi: 10.1016/j.rbmo.2017.05.004. Epub 2017 May 17.
PubMed 28601378Tamura H, Takasaki A, Nakamura Y, Numa F, Sugino N. A pilot study to search possible mechanisms of ultralong gonadotropin-releasing hormone agonist therapy in IVF-ET patients with endometriosis. J Ovarian Res. 2014 Oct 21;7:100. doi: 10.1186/s13048-014-0100-8.
PubMed 25331066Horne AW, Missmer SA. Pathophysiology, diagnosis, and management of endometriosis. BMJ. 2022 Nov 14;379:e070750. doi: 10.1136/bmj-2022-070750.
PubMed 36375827
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Ultra-Long GnRH-a Pretreatment to Improve Frozen-Thawed Embryo Transfer Outcomes in Patients With Deep Infiltrating Endometriosis
- ClinicalTrials.gov ID
- NCT07696351
- Acronym / sponsor ID
- DIE-GnRHa-FET / DIE-GnRHa-FET-RCT-2025-01
- Conditions
- Deep Infiltrating Endometriosis (DIE), Infertility
- Keywords
- Deep infiltrating endometriosis, GnRH-a, Triptorelin, Frozen-thawed embryo transfer, Hormone replacement therapy, Clinical pregnancy rate, Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Li-jun DingUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 10 Jul 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.
Deep infiltrating endometriosis is a severe form of endometriosis that may reduce fertility and negatively affect pregnancy outcomes after assisted reproductive treatment. Gonadotropin-releasing hormone agonist pretreatment may suppress endometriotic lesions, reduce inflammation, and improve endometrial receptivity, but its benefit before frozen-thawed embryo transfer remains uncertain.
This randomized controlled study will evaluate whether ultra-long GnRH-a pretreatment before hormone replacement therapy improves clinical pregnancy outcomes in patients with deep infiltrating endometriosis undergoing their first frozen-thawed embryo transfer cycle. Eligible participants will be randomly assigned to either the GnRH-a pretreatment group or the control group. Participants in the GnRH-a group will receive two injections of long-acting GnRH-a before hormone replacement therapy for endometrial preparation, while participants in the control group will receive routine hormone replacement therapy alone.
The primary outcome is clinical pregnancy rate, defined as the presence of a gestational sac on transvaginal ultrasound 30 ± 3 days after embryo transfer. Secondary outcomes include implantation rate, ectopic pregnancy rate, early spontaneous abortion rate, ongoing pregnancy rate at 12 weeks of gestation, and delivery rate. Safety will be evaluated by recording adverse events after GnRH-a injection. The planned enrollment is 120 participants.
Detailed description
Deep infiltrating endometriosis is a severe subtype of endometriosis that may involve pelvic organs and is associated with infertility, impaired endometrial receptivity, chronic pelvic inflammation, reduced implantation, increased miscarriage risk, and poorer outcomes after assisted reproductive treatment. For patients with deep infiltrating endometriosis who require frozen-thawed embryo transfer, the optimal endometrial preparation strategy remains uncertain.
Gonadotropin-releasing hormone agonists may suppress ovarian estrogen production, inhibit the activity of endometriotic lesions, reduce inflammatory mediators, and potentially improve the endometrial environment before embryo transfer. However, current evidence regarding GnRH-a pretreatment before frozen-thawed embryo transfer in patients with endometriosis is inconsistent, and high-quality prospective randomized controlled studies are limited. This study is designed to evaluate whether ultra-long GnRH-a pretreatment improves pregnancy outcomes in patients with deep infiltrating endometriosis undergoing frozen-thawed embryo transfer.
This is a prospective, randomized, controlled, single-center clinical study. A total of 120 eligible participants will be enrolled. Participants must be younger than 40 years, diagnosed with deep infiltrating endometriosis by ultrasound at the study center, undergoing their first frozen-thawed embryo transfer cycle with hormone replacement therapy for endometrial preparation, and have at least one good-quality frozen embryo. Eligible participants will be randomly assigned in a 1:1 ratio to the experimental group or the control group.
Participants in the experimental group will receive ultra-long GnRH-a pretreatment before frozen-thawed embryo transfer. Long-acting GnRH-a will be administered on menstrual cycle days 2 to 4, followed by a second injection 28 to 30 days later. Hormone replacement therapy for endometrial preparation will begin 28 to 30 days after the second GnRH-a injection, followed by frozen-thawed embryo transfer according to routine clinical practice.
Participants in the control group will undergo routine hormone replacement therapy for endometrial preparation before frozen-thawed embryo transfer without GnRH-a pretreatment.
The primary outcome is clinical pregnancy rate, defined as the presence of a gestational sac detected by transvaginal ultrasound 30 ± 3 days after embryo transfer. Secondary outcomes include implantation rate, ectopic pregnancy rate, early spontaneous abortion rate, ongoing pregnancy rate at 12 weeks of gestation, and delivery rate. Additional pregnancy, obstetric, and neonatal outcomes may be followed according to the study protocol, including biochemical pregnancy, late spontaneous abortion, preterm birth, stillbirth, live birth, pregnancy complications, delivery outcomes, and birth weight.
Safety will be assessed by monitoring and recording adverse events after GnRH-a injection, including hot flashes, headache, sleep disturbance, vaginal bleeding or spotting, night sweats, and mood changes. Participants will be followed after embryo transfer and, if pregnancy occurs, through pregnancy and delivery according to the protocol-defined follow-up schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the ultra-long GnRH-a pretreatment group or the routine hormone replacement therapy control group. The two groups will be compared in parallel to evaluate the effect of GnRH-a pretreatment on frozen-thawed embryo transfer outcomes.
| Arm | Type | Receives |
|---|---|---|
| Ultra-Long GnRH-a Pretreatment Group | Experimental | Drug: Triptorelin (GnRH agonists)Participants in this group will receive ultra-long GnRH-a pretreatment before frozen-thawed embryo transfer. Long-acting GnRH-a will be administered on menstrual cycle days 2 to 4, followed by a second injection 28 to 30 days later. Hormone replacement therapy for endometrial preparation will begin 28 to 30 days after the second GnRH-a injection, followed by frozen-thawed embryo transfer according to routine clinical practice. |
| Routine HRT Group | Active comparator | Other: Hormone Replacement Therapy (HRT)Participants in this group will undergo routine hormone replacement therapy for endometrial preparation before frozen-thawed embryo transfer without GnRH-a pretreatment. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged 18 to 39 years.
- Diagnosed with deep infiltrating endometriosis by ultrasound at the study center.
- Undergoing the first frozen-thawed embryo transfer cycle with hormone replacement therapy for endometrial preparation.
- Having at least one good-quality frozen embryo.
- Willing to participate in this randomized controlled study of GnRH-a pretreatment for deep infiltrating endometriosis and able to personally sign the written informed consent form.
Key exclusion criteria (7 listed)
- Abnormal chromosomal karyotype.
- Other uterine diseases or conditions that may affect uterine cavity morphology or pregnancy outcomes, including intrauterine adhesions affecting the uterine cavity, intramural uterine fibroids, moderate to severe adenomyosis, congenital uterine malformation, endometrial tuberculosis, or endometrial thickness less than 8 mm on the transformation day.
- Recurrent implantation failure.
- Contraindications to hormone replacement therapy or long-acting GnRH-a treatment.
- Osteoporosis or depressed mood.
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 |
|---|---|---|
| Triptorelin (GnRH agonists)Also: GnRHaLong-acting GnRH-a pretreatment will be administered before hormone replacement therapy for endometrial preparation. Participants will receive two injections of triptorelin 3.75 mg: the first on menstrual cycle days 2 to 4 and the second 28 to 30 days later. | Drug | Ultra-Long GnRH-a Pretreatment Group |
| Hormone Replacement Therapy (HRT)Also: HRTRoutine hormone replacement therapy will be used for endometrial preparation before frozen-thawed embryo transfer. | Other | Routine HRT Group |
Primary outcome
Clinical Pregnancy Rate
Time frame: 30 ± 3 days after embryo transfer
Clinical pregnancy is defined as the presence of a gestational sac detected by transvaginal ultrasound 30 ± 3 days after embryo transfer. Clinical pregnancy rate will be calculated as the number of clinical pregnancy cycles divided by the total number of embryo transfer cycles.
5 secondary outcomes
Implantation Rate
Time frame: 30 ± 3 days after embryo transfer
Ectopic Pregnancy Rate
Time frame: Up to 49 ± 7 days after embryo transfer
Early Spontaneous Abortion Rate
Time frame: Up to 12 weeks of gestation
Ongoing Pregnancy Rate at 12 Weeks of Gestation
Time frame: 12 weeks of gestation
Delivery Rate
Time frame: At delivery, up to study completion
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 10 Jul 2026.
- Results publication: PubMed 28601378Surrey ES, Katz-Jaffe M, Kondapalli LV, Gustofson RL, Schoolcraft WB. GnRH agonist administration prior to embryo transfer in freeze-all cycles of patients with endometriosis or aberrant endometrial integrin expression. Reprod Biomed Online. 2017 Aug;35(2):145-151. doi: 10.1016/j.rbmo.2017.05.004. Epub 2017 May 17.
- Results publication: PubMed 25331066Tamura H, Takasaki A, Nakamura Y, Numa F, Sugino N. A pilot study to search possible mechanisms of ultralong gonadotropin-releasing hormone agonist therapy in IVF-ET patients with endometriosis. J Ovarian Res. 2014 Oct 21;7:100. doi: 10.1186/s13048-014-0100-8.
- Results publication: PubMed 36375827Horne AW, Missmer SA. Pathophysiology, diagnosis, and management of endometriosis. BMJ. 2022 Nov 14;379:e070750. doi: 10.1136/bmj-2022-070750.
- 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.
Yuan Yan contact
Jie Mei principal investigator
Department of Reproductive Medicine, 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 Phase 4 study testing Triptorelin (GnRH agonists) and Hormone Replacement Therapy (HRT) in people with Deep Infiltrating Endometriosis (DIE) and Infertility, run by Li-jun Ding 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 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: looking for participants now, as of the sponsor's last update on 10 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jie Mei, PhD (+86 15051839536 Email, meijie560@163.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: 30 ± 3 days after embryo transfer). 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 NCT07696351, which also lists 3 linked publications.
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 10 Jul 2026.