FET in Adenomyosis

NCT ID: NCT06913075

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-01-23

Brief Summary

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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.

Detailed Description

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Conditions

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Adenomyosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type ACTIVE_COMPARATOR

GnRH agonist downregulation

Intervention Type DRUG

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

Group B

Group Type ACTIVE_COMPARATOR

GnRH agonist and Letrozole

Intervention Type 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

Interventions

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GnRH agonist downregulation

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Indira IVF Hospital Pvt Ltd

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Indira IVF Pvt Hospital

Udaipur, Rajasthan, India

Site Status

Countries

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India

Central Contacts

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Taruna Jhamb, MD

Role: CONTACT

+91 9799035674

Facility Contacts

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Vipin Chandra, DGO

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22832421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28865548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36549997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37149412 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37822471 (View on PubMed)

Other Identifiers

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IIHL/UDR/P/003_2024

Identifier Type: -

Identifier Source: org_study_id

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