Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis
Recruiting · NCT07696351 · Interventional (participants receive a specific treatment) · Lead sponsor: Li-jun Ding
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- The Affiliated Drum Tower Hospital of Nanjing University Medical School - Nanjing, Jiangsu, China