NCT07696351 Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis
| NCT ID | NCT07696351 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Li-jun Ding |
| Condition | Deep Infiltrating Endometriosis (DIE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-08-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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.
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged 18 to 39 years. 2. Diagnosed with deep infiltrating endometriosis by ultrasound at the study center. 3. Undergoing the first frozen-thawed embryo transfer cycle with hormone replacement therapy for endometrial preparation. 4. Having at least one good-quality frozen embryo. 5. 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. Exclusion Criteria: 1. Abnormal chromosomal karyotype. 2. 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. 3. Recurrent implantation failure. 4. Contraindications to hormone replacement therapy or long-acting GnRH-a treatment. 5. Osteoporosis or depressed mood. 6. Currently participating in another clinical study. 7. Unable to adhere to study visits and follow-up, or planning to receive other treatment during the follow-up period.
Contact & Investigator
Jie Mei
PRINCIPAL INVESTIGATOR
Department of Reproductive Medicine, Nanjing Drum Tower Hospital
Frequently Asked Questions
Who can join the NCT07696351 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 39 Years, studying Deep Infiltrating Endometriosis (DIE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07696351 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07696351 currently recruiting?
Yes, NCT07696351 is actively recruiting participants. Contact the research team at meijie560@163.com for enrollment information.
Where is the NCT07696351 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT07696351 clinical trial?
NCT07696351 is sponsored by Li-jun Ding. The principal investigator is Jie Mei at Department of Reproductive Medicine, Nanjing Drum Tower Hospital. The trial plans to enroll 120 participants.