FET in Adenomyosis

NCT06913075 | Not Yet Recruiting DMC

• 1 other identifier: IIHL/UDR/P/003_2024
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Frozen embryo transfer; Adenomyosis; ongoing pregnancy rate; live birth rate

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  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%

  12 weeks of gestation

Secondary Outcomes (6)

• Implantation Rate

  4 weeks after embryo transfer

• Chemical Pregnancy rate

  4 weeks after embryo transfer

• Biochemical loss rate

  4 weeks after embryo transfer

• 1st trimester loss

  12 weeks of gestation

• 2nd trimester loss

  20 weeks of gestation

Study Arms (2)

Group A

ACTIVE COMPARATOR

Drug: GnRH agonist downregulation

Group B

ACTIVE COMPARATOR

Drug: GnRH agonist and Letrozole

Interventions

GnRH agonist downregulation DRUG

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

Group A

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

Group B

Eligibility Criteria

• Age: 21 Years - 42 Years
• Gender Eligibility Details: Women diagnosed with adenomyosis who are undergoing frozen embryo transfer (FET) as part of their fertility treatment.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indira IVF Hospital Pvt Ltd: lead

Study Sites (1)

Indira IVF Pvt Hospital

Udaipur, Rajasthan, 313001, India

Location

Related Publications (5)

• Salim R, Riris S, Saab W, Abramov B, Khadum I, Serhal P. Adenomyosis reduces pregnancy rates in infertile women undergoing IVF. Reprod Biomed Online. 2012 Sep;25(3):273-7. doi: 10.1016/j.rbmo.2012.05.003. Epub 2012 May 23.

  PMID: 22832421 RESULT

• Younes G, Tulandi T. Effects of adenomyosis on in vitro fertilization treatment outcomes: a meta-analysis. Fertil Steril. 2017 Sep;108(3):483-490.e3. doi: 10.1016/j.fertnstert.2017.06.025.

  PMID: 28865548 RESULT

• Han B, Liang T, Zhang W, Ma C, Qiao J. The effect of adenomyosis types on clinical outcomes of IVF embryo transfer after ultra-long GnRH agonist protocol. Reprod Biomed Online. 2023 Feb;46(2):346-351. doi: 10.1016/j.rbmo.2022.09.021. Epub 2022 Sep 26.

  PMID: 36549997 RESULT

• Sharma S, RoyChoudhury S, Bhattacharya MP, Hazra S, Majhi AK, Oswal KC, Chattopadhyay R. Low-dose letrozole - an effective option for women with symptomatic adenomyosis awaiting IVF: a pilot randomized controlled trial. Reprod Biomed Online. 2023 Jul;47(1):84-93. doi: 10.1016/j.rbmo.2023.03.010. Epub 2023 Mar 18.

  PMID: 37149412 RESULT

• Li Y, Ge L, Yang X, Cui L, Chen ZJ. Effects of duration of long-acting GnRH agonist downregulation on assisted reproductive technology outcomes in patients with adenomyosis: a retrospective cohort study. Front Med (Lausanne). 2023 Sep 26;10:1248274. doi: 10.3389/fmed.2023.1248274. eCollection 2023.

  PMID: 37822471 RESULT

MeSH Terms

Conditions

Adenomyosis

Interventions

Gonadotropin-Releasing Hormone; Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Taruna Jhamb, MD

CONTACT

+91 9799035674; centerhead.udaipur@indiraivf.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: April 6, 2025
• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 23, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication

Locations

IN (1)