Ultra-Long GnRH-a Pretreatment Before Frozen Embryo Transfer for Deep Infiltrating Endometriosis
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
Run by Nanjing University · NCT07696351 · Data updated 2026-11-12
In people under 40 with deep infiltrating endometriosis and infertility, the study tests whether two injections of a GnRH agonist before hormone support improve pregnancy outcomes in their first frozen-thawed embryo transfer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 39 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Nanjing University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | July 31, 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT07696351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18-39 with ultrasound-confirmed DIE undergoing their first FET cycle and having at least one good-quality frozen embryo.
✕Probably not a fit
Patients without DIE or those not undergoing FET or with contraindications to GnRH-a may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, single-center trial will compare ultra-long GnRH-a pretreatment followed by hormone replacement therapy to standard preparation in women with deep infiltrating endometriosis undergoing their first FET. 120 eligible participants will be randomly assigned to receive triptorelin and then HRT versus HRT alone. The study aims to see if suppressing endometriotic activity before embryo transfer improves clinical pregnancy outcomes. Medical history, ultrasound confirmation of DIE, embryo quality, and pregnancy outcomes will be tracked.
Why it matters
Potential benefit: If successful, the approach could improve pregnancy rates for people with DIE undergoing FET.
How similar studies have gone: Existing evidence on GnRH-a pretreatment before FET in DIE is mixed, with limited high-quality randomized data.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China Recruiting
Study contacts
- Principal investigator: Jie Mei — Department of Reproductive Medicine, Nanjing Drum Tower Hospital
- Study coordinator: Jie Mei, PhD
- Email: meijie560@163.com
- Phone: +86 15051839536 Email
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.