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Starting soon Not applicable

FET in Adenomyosis

NCT06913075 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2026-06-25
Last updated
2026-01-26

Condition(s) studied

Adenomyosis

Investigational drug(s) / intervention(s)

GnRH agonist downregulationGnRH agonist and Letrozole

GnRH agonist downregulation: Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval

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

Study 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.

Eligibility

Sex
FEMALE
Min age
21 Years
Max age
42 Years
Healthy volunteers
No
Inclusion Criteria: Diagnosis of adenomyosis confirmed via transvaginal ultrasound as per MUSA criteria History of infertility requiring frozen embryo transfer (FET). Availability of at least one good-quality frozen embryo for transfer Exclusion Criteria: BMI ≥ 30 kg/m2 Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome Previous major uterine surgery Gestational carrier Fertility preservation

Primary outcome measure(s)

  • Ongoing pregnancy rate — 12 weeks of gestation
    Presence of gestational sacs with a heartbeat at the 12th gestational week. The ongoing pregnancy rate will be calculated using the below formula. Ongoing pregnancy rate: (the number of ongoing pregnancy cases/the number of clinical pregnancy cases) × 100%

Trial sites (1)

FacilityCityRegionStatus
Indira IVF Pvt Hospital Udaipur Rajasthan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06913075 on ClinicalTrials.gov ↗ ← All trials in India