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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
700
Triptorelin Acetate 3.75mg for two consecutive dosage at 30 days interval
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
Indira IVF Pvt Hospital
Udaipur, Rajasthan, India
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%
Time frame: 12 weeks of gestation
Implantation Rate
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
Time frame: 4 weeks after embryo transfer
Chemical Pregnancy rate
Detection of a fetal heartbeat on transvaginal ultrasound at the 6th gestational week. The clinical pregnancy rate will be calculated using the below formula.
Time frame: 4 weeks after embryo transfer
Biochemical loss rate
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%
Time frame: 4 weeks after embryo transfer
1st trimester loss
First-trimester loss refers to the spontaneous loss of a pregnancy occurring before the end of the 12th week of gestation
Time frame: 12 weeks of gestation
2nd trimester loss
Second-trimester loss refers to the spontaneous loss of a pregnancy occurring between 13 and 20 weeks of gestation.
Time frame: 20 weeks of gestation
Live Birth Rate
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
Time frame: Post delivery after completion of 20 weeks of gestation
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