A Phase 3 interventional study of Human chorionic gonadotropin (hCG) and Follitropin delta in Low Ovarian Reserve and Poor Ovarian Response, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Phase 3, Interventional, and Treatment
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.
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.
Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 73 studies on the registry; 18 are open to participants now.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ovulation triggering using human chorionic gonadotropin (hCG) alone.
Drug: Human chorionic gonadotropin (hCG)
Ovulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG).
Drug: Human chorionic gonadotropin (hCG) · Drug: Follitropin delta
Ovulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG).
Drug: Human chorionic gonadotropin (hCG) · Drug: Triptorelin
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
Also known as: hCG
Follitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation. (hCG).
Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation.
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
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
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
Ongoing pregnancy rate
Presence of a viable intrauterine pregnancy confirmed by ultrasound.
Time frame: 6-7 weeks of gestation
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Studies of the drugs tested here: Follitropin delta · Triptorelin
Fundación para la Investigación del Hospital Clínico de Valencia