Adenomyosis
Conditions
Keywords
Frozen embryo transfer, Adenomyosis, ongoing pregnancy rate, live birth rate
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.
Interventions
DRUGGnRH agonist downregulation
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
Sponsors
Indira IVF Hospital Pvt Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 42 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Implantation Rate | 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 |
| Live Birth Rate | 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 |
| Biochemical loss rate | 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 | 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 | 20 weeks of gestation | Second-trimester loss refers to the spontaneous loss of a pregnancy occurring between 13 and 20 weeks of gestation. |
| Chemical Pregnancy rate | 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. |
Countries
India
Contacts
CONTACTTaruna Jhamb, MD
Outcome results
None listed