Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis

Short name DIE-GnRHa-FET

NCTNCT07696351Other idDIE-GnRHa-FET-RCT-2025-01Other id2025-0564

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 120 participants (estimated)
Sponsor: Li-jun Ding · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 1 Aug 2025
Primary completion: 31 Dec 2026 (estimated)
Completion: 31 Jul 2027 (estimated)
First posted: 10 Jul 2026
Last update posted: 10 Jul 2026
Conditions: Deep Infiltrating Endometriosis (DIE) · Infertility

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2025202620272028

Ph 4
DIE-GnRHa-FET
NCT07696351
1 Aug 2025 to est. 31 Jul 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Triptorelin (GnRH agonists)Drug
Hormone Replacement Therapy (HRT)Other

Arms2

Experimental
Ultra-Long GnRH-a Pretreatment Group
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.
Active comparator
Routine HRT Group
Participants in this group will undergo routine hormone replacement therapy for endometrial preparation before frozen-thawed embryo transfer without GnRH-a pretreatment.

Primary outcomes1

Outcomes the sponsor listed as primary.

Clinical Pregnancy Rate
Time frame · 30 ± 3 days after embryo transfer
Registry description
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.

Secondary outcomes(5)

Implantation Rate
Time frame · 30 ± 3 days after embryo transfer
Registry description
Implantation rate will be calculated based on the number of gestational sacs observed by ultrasound relative to the number of embryos transferred.
Ectopic Pregnancy Rate
Time frame · Up to 49 ± 7 days after embryo transfer
Registry description
Ectopic pregnancy rate will be calculated as the number of ectopic pregnancy cases divided by the total number of embryo transfer cycles.
Early Spontaneous Abortion Rate
Time frame · Up to 12 weeks of gestation
Registry description
Early spontaneous abortion rate will be calculated as the number of early spontaneous abortions divided by the number of clinical pregnancy cycles.
Ongoing Pregnancy Rate at 12 Weeks of Gestation
Time frame · 12 weeks of gestation
Registry description
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.
Delivery Rate
Time frame · At delivery, up to study completion
Registry description
Delivery rate will be calculated as the number of participants who deliver divided by the total number of embryo transfer cycles.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultSurrey 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. PMID 28601378
ResultTamura 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. PMID 25331066
ResultHorne AW, Missmer SA. Pathophysiology, diagnosis, and management of endometriosis. BMJ. 2022 Nov 14;379:e070750. doi: 10.1136/bmj-2022-070750. PMID 36375827

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 39 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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