Study Results
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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NOT_YET_RECRUITING
NA
700 participants
INTERVENTIONAL
2025-06-25
2026-01-23
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A
GnRH agonist downregulation
Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval
Group B
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
42 Years
FEMALE
No
Sponsors
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Indira IVF Hospital Pvt Ltd
OTHER
Responsible Party
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Locations
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Indira IVF Pvt Hospital
Udaipur, Rajasthan, India
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
Other Identifiers
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IIHL/UDR/P/003_2024
Identifier Type: -
Identifier Source: org_study_id
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