GnRH Agonist Pretreatment Duration and Letrozole Supplementation in Frozen Embryo Transfer for Adenomyosis Patients

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-38
SponsorFirst Affiliated Hospital, Sun Yat-Sen University

About this trial

This randomized clinical trial aims to assess the comparative effectiveness of different pre-treatment protocols prior to frozen embryo transfer (FET) among women with adenomyosis, providing evidence-based guidance for clinical decision-making. The main questions it aims to answer are:

Does the protocol involving two doses of gonadotropin-releasing hormone agonist (GnRH-a) pretreatment result in a higher live birth rate compared to one dose of GnRH-a pretreatment in women with adenomyosis undergoing frozen embryo transfer? Does the protocol involving GnRH-a with letrozole supplementation result in a higher live birth rate compared to GnRH-a monotherapy in women with adenomyosis undergoing frozen embryo transfer? Eligible participants will undergo screening before endometrial preparation for FET, following which they will be randomly assigned to one of four groups: GnRH-a-1M, GnRH-a-2M, GnRH-a+LE-1M or GnRH-a+LE-2M. In the GnRH-a-1M group, participants will be pre-treated with one dose GnRH agonist before endometrial preparation. In the GnRH-a-2M group, participants will be pre-treated with two doses GnRH agonist before endometrial preparation. In the GnRH-a+LE-1M group, participants will be pre-treated with one dose GnRH agonist and letrozole 28 days before endometrial preparation. In the GnRH-a+LE-2M group, participants will be pre-treated with two doses GnRH agonist, along with daily 2.5 mg letrozole for 28 days since the first injection of GnRH agonist before endometrial preparation. After pre-treament, all participants will return for endometrial preparation in artificial cycles.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sonographically diagnosed adenomyosis via transvaginal ultrasound;

Candidates scheduled for frozen single blastocyst (Day5, Day6) transfer

Age 20-38 years

Previous embryo transfer attempts: ≤2 cycles

Disqualifiers

Patients diagnosed with Recurrent pregnancy loss, Autoimmune disorders (e.g., systemic lupus erythematosus), Uterine fibroids ≥5 cm, Cervical incompetence, Cesarean scar niche

History of Myomectomy and/or adenomyosis lesion excision, Cervical conization

Patients presenting with Congenital Müllerian anomalies (unicornuate uterus, septate uterus, etc.), Endometrial atypical hyperplasia, malignancy or defects

Sperm retrieval method: Micro-TESE (microdissection testicular sperm extraction)

Trial design

Design model

Factorial

Treatments tested in this trial

  • GnRH-a-1M

    Drug

    Pre-treatment with one dose GnRH agonist before endometrial preparation.

  • GnRH-a-2M

    Drug

    Pre-treatment with two doses GnRH agonist before endometrial preparation.

  • GnRH-a+LE-1M

    Drug

    Pre-treatment with one dose GnRH agonist, along with daily 2.5 mg letrozole for 28 days before endometrial preparation.

  • GnRH-a+LE-2M

    Drug

    Pre-treatment with two doses GnRH agonist, along with daily 2.5 mg letrozole for 28 days since the first injection of GnRH agonist before endometrial preparation.

Treatment groups

432 Participants
are divided into 4 treatment groups
Group A: GnRH-a-1MActive comparator 1 intervention
Group B: GnRH-a-2MActive comparator 1 intervention
Group C: GnRH-a+LE-1MActive comparator 1 intervention
Group D: GnRH-a+LE-2MActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Live birth rate

Time frame
40 weeks after embryo transfer

Secondary outcomes

1

Cycle Cancellation Rate

Time frame
3 weeks after initiating artificial cycle
2

Hypoestrogenic Adverse Event Rate

Time frame
4 weeks after 3.75mg GnRH-a intramuscular injection
3

Positive Pregnancy Test Rate

Time frame
2 weeks post embryo transfer
4

Embryo Implantation Rate

Time frame
3 weeks post embryo transfer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital, Sun Yat-Sen University

Lead sponsor

Fujian Maternity and Child Health Hospital

Collaborator

BoAi Hospital of Zhongshan

Collaborator

This trial is not recruiting at the moment. You can still explore other options: