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NCT Number: NCT06913075

FET in Adenomyosis

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.

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Key information

Conditions

Adenomyosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Uterine Diseases

Age range

21 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Indira IVF Pvt Hospital

Udaipur, Rajasthan, 313001, India

Location contact

Akanksha Jangid, MD

SUB_INVESTIGATOR

Amol Lunkad, MD

SUB_INVESTIGATOR

Nisha Tiwari, DNB

SUB_INVESTIGATOR

Pawan Yadav, MD

SUB_INVESTIGATOR

Peter Humaidan, DMSc

SUB_INVESTIGATOR

Pooja Shinde, DNB

SUB_INVESTIGATOR

Rinoy Sreedharan, MD

SUB_INVESTIGATOR

Snehadarshani Karnath, MD

SUB_INVESTIGATOR

Tanu Batra, DNB

SUB_INVESTIGATOR

Taruna Jhamb, MD

PRINCIPAL_INVESTIGATOR

Vipin Chandra, DGO

CONTACT

[email protected]

Vipin Chandra, DGO

SUB_INVESTIGATOR

Yasha Pandey, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRH agonist downregulation

Drug

Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval

GnRH agonist and Letrozole

Drug

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 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%

Secondary outcomes

  1. Implantation Rate

    Time frame: 4 weeks after embryo transfer

    The number of gestational sacs observed by transvaginal ultrasound at the 6th gestational week per the number of embryos transferred. The implantation rate will be calculated using the below formula.

    Implantation rate: (The number of gestational sacs observed/ number of embryos transferred) × 100

  2. Chemical Pregnancy rate

    Time frame: 4 weeks after embryo transfer

    Detection of a fetal heartbeat on transvaginal ultrasound at the 6th gestational week. The clinical pregnancy rate will be calculated using the below formula.

  3. Biochemical loss rate

    Time frame: 4 weeks after embryo transfer

    Pregnancies diagnosed only by β-human chorionic gonadotropin detection without a gestational sac visualized by vaginal ultrasound at the 6th gestational week. The biochemical loss rate will be calculated using the below formula.

    Biochemical loss rate: (the number of biochemical pregnancy loss cases/the number of women per group) × 100%

  4. 1st trimester loss

    Time frame: 12 weeks of gestation

    First-trimester loss refers to the spontaneous loss of a pregnancy occurring before the end of the 12th week of gestation

  5. 2nd trimester loss

    Time frame: 20 weeks of gestation

    Second-trimester loss refers to the spontaneous loss of a pregnancy occurring between 13 and 20 weeks of gestation.

  6. Live Birth Rate

    Time frame: Post delivery after completion of 20 weeks of gestation

    The number of deliveries that resulted in at least one live birth per 100 Embryo transferred cycle.

    Live birth rate: (The number of live births / the number of embryos transferred cycle) × 100

Study contacts

Contact information is provided by the study sponsor or research team.

Taruna Jhamb, MD

CONTACT

[email protected]

+91 9799035674

Sponsors and collaborators

Lead sponsor

Indira IVF Hospital Pvt Ltd

Other

Registry information

Official study title

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

Acronym: ADY

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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