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Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)

Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07816562
Acronym
TRIGGERBEST
Enrollment
126
Registered
2026-09-11
Start date
2024-09-17
Completion date
2028-01-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Ovarian Reserve, Poor Ovarian Response

Keywords

Low ovarian reserve, Follitropin delta, Ovulation trigger, Mature oocytes, IVF

Brief 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.

Detailed description

Final oocyte maturation is a critical step in assisted reproductive techniques (ART) and is largely determined by the ovulation triggering strategy. In women with low ovarian reserve, achieving an adequate number of mature oocytes remains a major challenge, even when established trigger protocols are used. Dual trigger strategies combining hCG and a GnRH agonist are widely used in this population, based on evidence suggesting improved oocyte maturation. However, despite this approach, oocyte yield and maturity often remain suboptimal. The addition of exogenous follicle-stimulating hormone (FSH) activity at the time of ovulation triggering has been proposed as a potential strategy to further optimize final oocyte maturation. Follitropin delta has a distinct pharmacokinetic profile and provides individualized FSH exposure based on ovarian reserve markers. Its use in combination with hCG at the time of triggering may enhance oocyte maturation without compromising endometrial receptivity. This prospective, randomized study compares three ovulation triggering strategies in women with low ovarian reserve undergoing fresh IVF cycles: hCG alone, follitropin delta combined with hCG, and dual triggering using a GnRH agonist plus hCG. Participants are randomly assigned to one of the three groups. The primary outcome is the number of mature oocytes (metaphase II, MII) obtained at oocyte retrieval. Secondary outcomes include the proportion of mature oocytes, biochemical pregnancy rate per embryo transfer, and ongoing pregnancy rate following fresh embryo transfer. The study aims to generate evidence to optimize ovulation triggering strategies in women with low ovarian reserve.

Interventions

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

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

DRUGTriptorelin

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

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia
Lead SponsorOTHER
Ferring Pharmaceuticals
CollaboratorINDUSTRY
Hospital Clínico Universitario de Valencia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Intervention model description

Participants are randomly assigned to one of three parallel groups, each receiving a different ovulation trigger strategy.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Number of mature oocytes (MII)During the oocyte retrieval procedureNumber of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering

Secondary

MeasureTime frameDescription
Proportion of mature oocytesDuring the oocyte retrieval procedurePercentage of metaphase II (MII) oocytes relative to the total number of oocytes retrieved.
Biochemical pregnancy rate per embryo transfer10-14 days after embryo transferPositive beta-human chorionic gonadotropin (beta-hCG) test following fresh embryo transfer.
Ongoing pregnancy rate6-7 weeks of gestationPresence of a viable intrauterine pregnancy confirmed by ultrasound.

Countries

Spain

Contacts

CONTACTCesar Lizan Tudela
cesarlizan@yahoo.es+34 96 197 3500
PRINCIPAL_INVESTIGATORCesar Lizan Tudela

Department of Obstetrics and Gynaecology, Hospital Clínico Universitario de Valencia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026