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Clinical Trials in Spain / NCT07816562
Recruiting Phase 3

Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)

NCT07816562 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
Phase
Phase 3
Started
2024-09-17
Last updated
2026-09-11

Condition(s) studied

Low Ovarian ReservePoor Ovarian Response

Investigational drug(s) / intervention(s)

Human chorionic gonadotropin (hCG) →Follitropin delta →Triptorelin →

Human chorionic gonadotropin (hCG): Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.

Follitropin delta: Follitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation. (hCG).

Triptorelin: Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation.

Study summary

This study aims to compare different ovulation triggering strategies in women with low ovarian reserve undergoing fresh in vitro fertilization (IVF) cycles.

Ovulation triggering is a key step in IVF treatment, as it determines final oocyte maturation prior to oocyte retrieval.

Participants are randomly assigned to one of three ovulation trigger approaches: human chorionic gonadotropin (hCG) alone, follitropin delta combined with hCG, or dual trigger using a gonadotropin-releasing hormone (GnRH) agonist plus hCG.

The primary objective is to evaluate wether adding follitropin delta at the time of triggering increases the number of matura oocytes obtained, without adversely affecting implantation rates. Pregnancy otucomes following fresh embryo transfer will also be assessed.

The results of this study may help optimize ovulation triggering strategies in women with low ovarian reserve undergoing IVF treatment.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
42 Years
Healthy volunteers
No
Inclusion Criteria: * Signed informed consent. * Women aged between 18 and 42 years. * Primary infertility. * Women with low ovarian response classified within one of the groups defined by the POSEIDON criteria. Exclusion Criteria: * More than two previous failed ovarian stimulation cycles. * Female age \>42 years. * Body mass index (BMI) \>35 kg/m². * Criteria of extremely low ovarian reserve according to the Spanish National Health System exclusion criteria (AMH \<0.3 ng/mL and/or antral follicle count \<5). * Male partner age \>55 years. * Severe male factor infertility (total motile sperm count \<1 million). * Previous voluntary sterilization (vasectomy or bilateral tubal ligation). * Previous healthy child shared by the couple. * Presence of medical conditions contraindicating pregnancy. * Risk of ovarian hyperstimulation syndrome (OHSS). If more than 15 follicles are expected on the day of trigger, the patient will be excluded from the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clínico Universitario de Valencia Valencia Spain Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07816562 on ClinicalTrials.gov ↗ ← All trials in Spain