Ultra-Long GnRH-a Pretreatment for FET Outcomes in Patients With Deep Infiltrating Endometriosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorLi-jun Ding
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Triptorelin (GnRH agonists)
DrugLong-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.
Hormone Replacement Therapy (HRT)
Other interventionRoutine hormone replacement therapy will be used for endometrial preparation before frozen-thawed embryo transfer.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Ultra-Long GnRH-a Pretreatment GroupExperimental treatment 1 intervention
Group B: Routine HRT GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Pregnancy Rate
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.
Time frame
30 ± 3 days after embryo transferSecondary outcomes
1
Implantation Rate
Implantation rate will be calculated based on the number of gestational sacs observed by ultrasound relative to the number of embryos transferred.
Time frame
30 ± 3 days after embryo transfer2
Ectopic Pregnancy Rate
Ectopic pregnancy rate will be calculated as the number of ectopic pregnancy cases divided by the total number of embryo transfer cycles.
Time frame
Up to 49 ± 7 days after embryo transfer3
Early Spontaneous Abortion Rate
Early spontaneous abortion rate will be calculated as the number of early spontaneous abortions divided by the number of clinical pregnancy cycles.
Time frame
Up to 12 weeks of gestation4
Ongoing Pregnancy Rate at 12 Weeks of Gestation
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.
Time frame
12 weeks of gestationOther outcomes
1
Incidence of Adverse Events After GnRH-a Injection
Adverse events after long-acting GnRH-a injection will be recorded, including hot flashes, headache, sleep disturbance, vaginal bleeding or spotting, night sweats, and mood changes.
Time frame
From first GnRH-a injection to embryo transferSponsors and contacts
Click on the lead sponsor to view all of their trials.
Li-jun Ding
Lead sponsor
Nanjing University
Sponsor institution
Source ClinicalTrials.gov