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Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)

ConditionsLow Ovarian ReservePoor Ovarian Response
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorFundación para la Investigación del Hospital Clínico de Valencia

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Human chorionic gonadotropin (hCG)

    Drug

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

  • Follitropin delta

    Drug

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

  • Triptorelin

    Drug

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

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: hCG aloneExperimental treatment 1 intervention
Group B: Follitropin delta + hCGExperimental treatment 2 interventions
Group C: Dual triggerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of mature oocytes (MII)

Number of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering

Time frame
During the oocyte retrieval procedure

Secondary outcomes

1

Proportion of mature oocytes

Percentage of metaphase II (MII) oocytes relative to the total number of oocytes retrieved.

Time frame
During the oocyte retrieval procedure
2

Biochemical pregnancy rate per embryo transfer

Positive beta-human chorionic gonadotropin (beta-hCG) test following fresh embryo transfer.

Time frame
10-14 days after embryo transfer
3

Ongoing pregnancy rate

Presence of a viable intrauterine pregnancy confirmed by ultrasound.

Time frame
6-7 weeks of gestation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación para la Investigación del Hospital Clínico de Valencia

Lead sponsor

Ferring Pharmaceuticals

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

Source ClinicalTrials.gov
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