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The rise in frozen embryo transfer (FET) cycles within assisted reproductive technology (ART) has sparked the need to refine endometrial preparation protocols. The switch from hormone replacement cycles (HRT) to natural cycles, poses scheduling challenges onto laboratories, doctors and patients. The modified natural cycle (mNC), offering more precision for scheduling, shows promise but lacks comprehensive data on the potential flexibility of triggering criteria that may allow to control timing in a wider range.
This prospective randomized study seeks to address this knowledge gap by evaluating the non-inferiority of triggering ovulation in mNC with follicle diameters of 13-16.9mm compared to the conventional 17-22mm.
The study aims to enhance the understanding of the impact of follicle size at ovulation in reproductive outcomes, optimize FET treatments providing a more flexible mNC protocol, and improve patient care in ART clinics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Trigger indicated as per standard clinical practice at folicular diameter of at least 17mm | |
| Early trigger | Experimental | Trigger indicated at folicular diameter smaller than standard clinical practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trigger at smaller folicular size | Procedure | Trigger indicated at folicular diameter smaller than standard clinical practice, from 13mm to 16.9mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Rate of positive pregnancies over total transfers performed, according to beta-test result | From embryo transfer up to 2 weeks later |
| Measure | Description | Time Frame |
|---|---|---|
| Implantation rate | Implantation rate, defined as number of gestational sacs per embryos transferred | up to 8 weeks of gestational age |
| Cancelation rate | Number of cancelled embryo transfers per initiated endometrial preparation cycles. Transfer canceling implies end of study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manuel Fernández Sánchez, MD PhD | Contact | +34954286274 | vida.investiga@gruporecoletas.com | |
| Clara Palacio de Marco, MSc | Contact | +34954286274 | clara.palacio@gruporecoletas.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vida Recoletas Sevilla | Recruiting | Seville | Sevilla | 41092 | Spain |
All IPD collected throughout the trial.
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Prospective open randomized parallel group 1:1 ratio
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| Perioperative/Periprocedural |
| Miscarriage rate | Number of miscarriages of any type registered after transfer during the study, per total number of transfers performed | From embryo transfer to delivery, up to 40 weeks |