NCT07696351RecruitingPhase 4
Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis
A Randomized Controlled Study of Ultra-Long GnRH-a Pretreatment to Improve Frozen-Thawed Embryo Transfer Outcomes in Patients With Deep Infiltrating Endometriosis
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Aug 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Li-jun Ding
- Diseases
- Endometriosis
- NCT number
- NCT07696351
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 120
- From 1 Aug 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to hormone replacement therapy or long-acting GnRH-a treatment.
Other illness
- 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.
Other
- Abnormal chromosomal karyotype.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 39 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Drum Tower Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.