Comparison of clinical pregnancy rates between hormone replacement therapy and modified natural cycle for endometrial preparation in frozen embryo transfer cycles: An RCT.

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This RCT found no significant difference in clinical pregnancy rates between hormone replacement therapy and modified natural cycles for endometrial preparation in frozen embryo transfer.

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This single-blind randomized clinical trial compared clinical pregnancy rates between modified natural cycle and hormone replacement therapy protocols for endometrial preparation in frozen embryo transfer cycles among 128 ovulatory women. The study excluded participants with diagnosed uterine anatomical abnormalities, hydrosalpinx, or endometriosis to isolate the effects of the synchronization methods on otherwise healthy recipients. Results indicated that while both protocols are viable options for endometrial preparation, the specific comparison focused on outcomes in a population explicitly free from these pathologies. Relevance to endometriosis: listed as an exclusion criterion rather than a focus of investigation.

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Abstract

BackgroundFrozen-thawed embryo transfer (FET) during the endometrial receptivity window is important for implantation.ObjectiveThis study aims to compare the clinical pregnancy rate in 2 methods of endometrial preparation in FET using the hormone replacement cycle (HRC) and the modified natural cycle (mNC).Materials and methodsIn this randomized clinical trial, 128 infertile women who visited the Imam Khomeini hospital infertility clinic, Sari, Iran between April and October 2024 were randomly assigned to 2 groups (n = 64/each): the mNC frozen embryo transfer group and the HRC group. In the mNC frozen embryo transfer group, ovulation was induced using human chorionic gonadotropin, and the timing of frozen embryo transfer was scheduled based on ovulation. The HRC group received estradiol valerate until the endometrial thickness reached 8 mm, then daily injections of progesterone were added and FET were performed.ResultsThe participants had no significant differences in demographic characteristics. The primary outcome was clinical pregnancy rate with no significant difference between two groups (p = 0.282). No significant differences were observed between the mNC and HRC groups regarding the secondary outcome, which included human chorionic gonadotropin positive rate, chemical pregnancy rate, implantation rate, ongoing pregnancy rate, early miscarriage, ectopic pregnancy, twin pregnancy, and cycle cancellation rate. Significant differences were observed in the number of monitoring visits between the mNC frozen embryo transfer and HRC groups (p = 0.001).ConclusionAlthough the results indicate that the impact of both methods is similar, the fact that fewer visits are required in a natural cycle and there is also less need for hormones could make it preferable.
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F. Safarloo contributed to the design and conceptualization of the study, selection of methodologies, and drafting of the manuscript. M. Zamaniyan was involved in data collection, analysis, and interpretation of the results. E. Nazar was responsible for data analysis and interpretation of the findings. K. Samadaee Gelehkolaee assisted in determining the research methodology and editing the manuscript draft. M. Omid participated in data collection and manuscript writing. S. Peivandi played a key role in interpreting the results, editing the manuscript, and providing general feedback throughout all stages of the research.

Coi Statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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