DRUG
GnRH agonist downregulation
Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval
Status
Not yet recruiting
Phase
Not applicable
Enrollment
700
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
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
Timeline
From registration to results.
First posted
Apr 6, 2025
Study start
Jun 25, 2026
Primary completion
Jul 15, 2026
Study completion
Dec 23, 2026
Results posted
Not reported
Registry updated
Jan 26, 2026
Outcomes
What the study measures.
Primary outcomes
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
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
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.
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%
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
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.
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
Eligibility
Who can take part.
- Minimum age
- 21 Years
- Maximum age
- 42 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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
Study locations
1 registered sites.
India. Showing up to 24 locations stored in the fast local snapshot.
Indira IVF Pvt Hospital
Udaipur, Rajasthan, India
Publications
Results and literature.
PMID 22832421 ↗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 28865548 ↗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 36549997 ↗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 37149412 ↗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 37822471 ↗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.
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