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RECRUITING
NCT07696351
PHASE4

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

Sponsor: Li-jun Ding

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-08-01

Completion Date

2027-07-31

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

Triptorelin (GnRH agonists)

Long-acting GnRH-a pretreatment will be administered before hormone replacement therapy for endometrial preparation. Participants will receive two injections of triptorelin 3.75 mg: the first on menstrual cycle days 2 to 4 and the second 28 to 30 days later.

OTHER

Hormone Replacement Therapy (HRT)

Routine hormone replacement therapy will be used for endometrial preparation before frozen-thawed embryo transfer.

Locations (1)

The Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China