NCT06913075

FET in Adenomyosis

Is GnRH Agonist Plus Letrozole a Better Choice Than GnRH Agonist Alone in Adenomyosis Cases Undergoing Frozen Embryo Transfer?

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Indira IVF Hospital Pvt Ltd · Academic / Other
• Sex: Female
• Age: 21 Years – 42 Years
• Healthy volunteers: Not accepted

Summary

Purpose of the Study: To compare the effectiveness of GnRH agonist downregulation alone versus GnRH agonist combined with letrozole in improving pregnancy outcomes in women with adenomyosis undergoing frozen embryo transfer (FET). Research Question: Is the combined use of GnRH agonist and letrozole more effective than GnRH agonist downregulation alone in achieving better ongoing pregnancy rates in adenomyosis cases undergoing FET? Hypothesis: Null Hypothesis (H₀): The combined use of GnRH agonist and letrozole is not more effective than GnRH agonist downregulation alone in achieving a higher ongoing pregnancy rate in adenomyosis cases undergoing FET. Study Outcomes: Primary Outcome: Ongoing pregnancy rate at 12 weeks of gestation.

Conditions

• Adenomyosis

Interventions

Type	Name	Description
DRUG	GnRH agonist downregulation	Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval
DRUG	GnRH agonist and Letrozole	Triptorelin Acetate 3.75mg for two consecutive dosages at 30 days interval) + Letrozole (5 mg once daily for a total of 21 days during the second depot - letrozole stops when Estrogen priming starts

Timeline

• Start date: 2026-06-25
• Primary completion: 2026-07-15
• Completion: 2026-12-23
• First posted: 2025-04-06
• Last updated: 2026-01-26

Locations

1 site across 1 country: India