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FET in Adenomyosis (ADY)

I

Indira IVF Hospital Pvt Ltd

Status

Begins enrollment in 4 months

Conditions

Adenomyosis

Treatments

Drug: GnRH agonist downregulation
Drug: GnRH agonist and Letrozole

Study type

Interventional

Funder types

Other

Identifiers

NCT06913075
IIHL/UDR/P/003_2024

Details and patient eligibility

About

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.

Enrollment

700 estimated patients

Sex

Female

Ages

21 to 42 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

700 participants in 2 patient groups

Group A
Active Comparator group
Treatment:
Drug: GnRH agonist downregulation
Group B
Active Comparator group
Treatment:
Drug: GnRH agonist and Letrozole

Trial contacts and locations

1

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Central trial contact

Taruna Jhamb, MD

Data sourced from clinicaltrials.gov

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