Triggering Ovulation at Follicle Size Smaller or Larger Than 17mm in a Modified Natural Cycle

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorVida Recoletas Sevilla

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least one expanded blastocyst (regardless of its quality)

Spontaneous menstrual cycles

Consent to undergo frozen embryo transfer in a modified natural cycle

Disqualifiers

Abnormal uterine cavity

Fluid in endometrial cavity

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trigger at smaller folicular size

    Procedure/Surgery

    Trigger indicated at folicular diameter smaller than standard clinical practice, from 13mm to 16.9mm

Treatment groups

572 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Early triggerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pregnancy rate

Rate of positive pregnancies over total transfers performed, according to beta-test result

Time frame
From embryo transfer up to 2 weeks later

Secondary outcomes

1

Implantation rate

Implantation rate, defined as number of gestational sacs per embryos transferred

Time frame
up to 8 weeks of gestational age
2

Cancelation rate

Number of cancelled embryo transfers per initiated endometrial preparation cycles. Transfer canceling implies end of study.

Time frame
Perioperative/Periprocedural
3

Miscarriage rate

Number of miscarriages of any type registered after transfer during the study, per total number of transfers performed

Time frame
From embryo transfer to delivery, up to 40 weeks

Other outcomes

Sponsors and contacts

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