Low Ovarian ReservePhase 3TRIGGERBESTNCT07816562
Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST)
A Phase 3 study testing Human chorionic gonadotropin (hCG), Follitropin delta and Triptorelin in people with Low Ovarian Reserve and Poor Ovarian Response, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Low Ovarian Reserve, Poor Ovarian Response
- What is being tested?
- Human chorionic gonadotropin (hCG), Follitropin delta and Triptorelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 17 Sep 2024to 1 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Valencia
Valencia, 46010
Cesar Lizan Tudela, +34 96 197 3500, cesarlizan@yahoo.es
About this study
Official title: Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)
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.
Read more
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.
Read the 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.
- Conditions
- Low Ovarian Reserve, Poor Ovarian Response
- Being tested
- Human chorionic gonadotropin (hCG), Follitropin delta, Triptorelin
- Keywords
- Low ovarian reserve, Follitropin delta, Ovulation trigger, Mature oocytes, IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human chorionic gonadotropin (hCG)Drug
Also called hCG
Human chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering.
Follitropin deltaDrug
Follitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation.
(hCG).
TriptorelinDrug
Triptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation.
| Study group | Role | What they receive |
|---|---|---|
| hCG alone | Experimental | Ovulation triggering using human chorionic gonadotropin (hCG) alone. Receives: Drug: Human chorionic gonadotropin (hCG) |
| Follitropin delta + hCG | Experimental | Ovulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG). Receives: Drug: Human chorionic gonadotropin (hCG); Drug: Follitropin delta |
| Dual trigger | Experimental | Ovulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG). Receives: Drug: Human chorionic gonadotropin (hCG); Drug: Triptorelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes (MII)
Number of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering
Measured: During the oocyte retrieval procedure
Secondary outcomes (3)
Proportion of mature oocytes
Percentage of metaphase II (MII) oocytes relative to the total number of oocytes retrieved.
Measured: During the oocyte retrieval procedure
Biochemical pregnancy rate per embryo transfer
Positive beta-human chorionic gonadotropin (beta-hCG) test following fresh embryo transfer.
Measured: 10-14 days after embryo transfer
Ongoing pregnancy rate
Presence of a viable intrauterine pregnancy confirmed by ultrasound.
Measured: 6-7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start17 Sep 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Low Ovarian ReserveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of three parallel groups, each receiving a different ovulation trigger strategy.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals, Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
- Investigators
- Cesar Lizan Tudela, Principal investigator, Department of Obstetrics and Gynaecology, Hospital Clínico Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816562
- Sponsor's protocol ID
- TRIGGERBEST
- Acronym
- TRIGGERBEST
- Status last verified
- Sep 2026
- First submitted
- 21 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kale A, Kale A. Oocyte Quality and Blastocyst Formation Rate with Dual Stimulation in Patients Belonging to POSEIDON Groups 3 and 4: A Retrospective Comparative Study. J Obstet Gynaecol India. 2023 Feb;73(1):57-61. doi: 10.1007/s13224-022-01703-1. Epub 2022 Oct 21.
PubMed 36879944Zhang Q, He S, Meng Y, Yin T, Ming L, Yang J, Li S. Effect of medroxyprogesterone acetate dose in progestin-primed ovarian stimulation on pregnancy outcomes in poor ovarian response patients with different body mass index levels. Front Endocrinol (Lausanne). 2024 Apr 18;15:1352522. doi: 10.3389/fendo.2024.1352522. eCollection 2024.
PubMed 38699386Chern CU, Li JY, Tsui KH, Wang PH, Wen ZH, Lin LT. Dual-trigger improves the outcomes of in vitro fertilization cycles in older patients with diminished ovarian reserve: A retrospective cohort study. PLoS One. 2020 Jul 6;15(7):e0235707. doi: 10.1371/journal.pone.0235707. eCollection 2020.
PubMed 32628729Alyasin A, Mehdinejadiani S, Ghasemi M. GnRH agonist trigger versus hCG trigger in GnRH antagonist in IVF/ICSI cycles: A review article. Int J Reprod Biomed. 2016 Sep;14(9):557-566.
PubMed 27738657Huang Z, Wells D. The human oocyte and cumulus cells relationship: new insights from the cumulus cell transcriptome. Mol Hum Reprod. 2010 Oct;16(10):715-25. doi: 10.1093/molehr/gaq031. Epub 2010 Apr 29.
PubMed 20435609Zhang Y, Yan Z, Qin Q, Nisenblat V, Chang HM, Yu Y, Wang T, Lu C, Yang M, Yang S, Yao Y, Zhu X, Xia X, Dang Y, Ren Y, Yuan P, Li R, Liu P, Guo H, Han J, He H, Zhang K, Wang Y, Wu Y, Li M, Qiao J, Yan J, Yan L. Transcriptome Landscape of Human Folliculogenesis Reveals Oocyte and Granulosa Cell Interactions. Mol Cell. 2018 Dec 20;72(6):1021-1034.e4. doi: 10.1016/j.molcel.2018.10.029. Epub 2018 Nov 21.
PubMed 30472193Wissing ML, Kristensen SG, Andersen CY, Mikkelsen AL, Host T, Borup R, Grondahl ML. Identification of new ovulation-related genes in humans by comparing the transcriptome of granulosa cells before and after ovulation triggering in the same controlled ovarian stimulation cycle. Hum Reprod. 2014 May;29(5):997-1010. doi: 10.1093/humrep/deu008. Epub 2014 Feb 7.
PubMed 24510971Haas J, Ophir L, Barzilay E, Yerushalmi GM, Yung Y, Kedem A, Maman E, Hourvitz A. GnRH agonist vs. hCG for triggering of ovulation--differential effects on gene expression in human granulosa cells. PLoS One. 2014 Mar 6;9(3):e90359. doi: 10.1371/journal.pone.0090359. eCollection 2014.
PubMed 24603682Parks JC, Patton AL, McCallie BR, Griffin DK, Schoolcraft WB, Katz-Jaffe MG. Corona cell RNA sequencing from individual oocytes revealed transcripts and pathways linked to euploid oocyte competence and live birth. Reprod Biomed Online. 2016 May;32(5):518-26. doi: 10.1016/j.rbmo.2016.02.002. Epub 2016 Feb 24.
PubMed 26995658Borgbo T, Povlsen BB, Andersen CY, Borup R, Humaidan P, Grondahl ML. Comparison of gene expression profiles in granulosa and cumulus cells after ovulation induction with either human chorionic gonadotropin or a gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2013 Oct;100(4):994-1001. doi: 10.1016/j.fertnstert.2013.05.038. Epub 2013 Jul 12.
PubMed 23856575Yu EJ, Choi WY, Park MS, Eum JH, Lee DR, Lee WS, Lyu SW, Yoon SY. RNA sequencing-based transcriptome analysis of granulosa cells from follicular fluid: Genes involved in embryo quality during in vitro fertilization and embryo transfer. PLoS One. 2023 Mar 1;18(3):e0280495. doi: 10.1371/journal.pone.0280495. eCollection 2023.
PubMed 36857405Uyar A, Torrealday S, Seli E. Cumulus and granulosa cell markers of oocyte and embryo quality. Fertil Steril. 2013 Mar 15;99(4):979-97. doi: 10.1016/j.fertnstert.2013.01.129.
PubMed 23498999Haahr T, Dosouto C, Alviggi C, Esteves SC, Humaidan P. Management Strategies for POSEIDON Groups 3 and 4. Front Endocrinol (Lausanne). 2019 Sep 11;10:614. doi: 10.3389/fendo.2019.00614. eCollection 2019.
PubMed 31572298
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovulation Trigger Strategies in Women With Low Ovarian Reserve Undergoing Fresh In Vitro Fertilization Cycles: A Prospective Randomized Controlled Trial (TRIGGERBEST)
- ClinicalTrials.gov ID
- NCT07816562
- Acronym / sponsor ID
- TRIGGERBEST / TRIGGERBEST
- Conditions
- Low Ovarian Reserve, Poor Ovarian Response
- Keywords
- Low ovarian reserve, Follitropin delta, Ovulation trigger, Mature oocytes, IVF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals, Hospital Clínico Universitario de Valencia
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- Participants are randomly assigned to one of three parallel groups, each receiving a different ovulation trigger strategy.
| Arm | Type | Receives |
|---|---|---|
| hCG alone | Experimental | Drug: Human chorionic gonadotropin (hCG)Ovulation triggering using human chorionic gonadotropin (hCG) alone. |
| Follitropin delta + hCG | Experimental | Drug: Human chorionic gonadotropin (hCG), Drug: Follitropin deltaOvulation triggering using follitropin delta in combination with human chorionic gonadotropin (hCG). |
| Dual trigger | Experimental | Drug: Human chorionic gonadotropin (hCG), Drug: TriptorelinOvulation triggering using a gonadotropin-releasing hormone (GnRH) agonist in combination with human chorionic gonadotropin (hCG). |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human chorionic gonadotropin (hCG)Also: hCGHuman chorionic gonadotropin (hCG) administered for final oocyte maturation and ovulation triggering. | Drug | Dual trigger, Follitropin delta + hCG, hCG alone |
| Follitropin deltaFollitropin delta administered as part of the ovulation-triggering regimen for final oocyte maturation. (hCG). | Drug | Follitropin delta + hCG |
| TriptorelinTriptorelin, a gonadotropin-releasing hormone (GnRH) agonist, administered as part of the ovulation-triggering regimen for final oocyte maturation. | Drug | Dual trigger |
Primary outcome
Number of mature oocytes (MII)
Time frame: During the oocyte retrieval procedure
Number of metaphase II (MII) oocytes obtained at oocyte retrieval following ovulation triggering
3 secondary outcomes
Proportion of mature oocytes
Time frame: During the oocyte retrieval procedure
Biochemical pregnancy rate per embryo transfer
Time frame: 10-14 days after embryo transfer
Ongoing pregnancy rate
Time frame: 6-7 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 36879944Kale A, Kale A. Oocyte Quality and Blastocyst Formation Rate with Dual Stimulation in Patients Belonging to POSEIDON Groups 3 and 4: A Retrospective Comparative Study. J Obstet Gynaecol India. 2023 Feb;73(1):57-61. doi: 10.1007/s13224-022-01703-1. Epub 2022 Oct 21.
- Background: PubMed 38699386Zhang Q, He S, Meng Y, Yin T, Ming L, Yang J, Li S. Effect of medroxyprogesterone acetate dose in progestin-primed ovarian stimulation on pregnancy outcomes in poor ovarian response patients with different body mass index levels. Front Endocrinol (Lausanne). 2024 Apr 18;15:1352522. doi: 10.3389/fendo.2024.1352522. eCollection 2024.
- Background: PubMed 32628729Chern CU, Li JY, Tsui KH, Wang PH, Wen ZH, Lin LT. Dual-trigger improves the outcomes of in vitro fertilization cycles in older patients with diminished ovarian reserve: A retrospective cohort study. PLoS One. 2020 Jul 6;15(7):e0235707. doi: 10.1371/journal.pone.0235707. eCollection 2020.
- Background: PubMed 27738657Alyasin A, Mehdinejadiani S, Ghasemi M. GnRH agonist trigger versus hCG trigger in GnRH antagonist in IVF/ICSI cycles: A review article. Int J Reprod Biomed. 2016 Sep;14(9):557-566.
- Background: PubMed 20435609Huang Z, Wells D. The human oocyte and cumulus cells relationship: new insights from the cumulus cell transcriptome. Mol Hum Reprod. 2010 Oct;16(10):715-25. doi: 10.1093/molehr/gaq031. Epub 2010 Apr 29.
- Background: PubMed 30472193Zhang Y, Yan Z, Qin Q, Nisenblat V, Chang HM, Yu Y, Wang T, Lu C, Yang M, Yang S, Yao Y, Zhu X, Xia X, Dang Y, Ren Y, Yuan P, Li R, Liu P, Guo H, Han J, He H, Zhang K, Wang Y, Wu Y, Li M, Qiao J, Yan J, Yan L. Transcriptome Landscape of Human Folliculogenesis Reveals Oocyte and Granulosa Cell Interactions. Mol Cell. 2018 Dec 20;72(6):1021-1034.e4. doi: 10.1016/j.molcel.2018.10.029. Epub 2018 Nov 21.
- Background: PubMed 24510971Wissing ML, Kristensen SG, Andersen CY, Mikkelsen AL, Host T, Borup R, Grondahl ML. Identification of new ovulation-related genes in humans by comparing the transcriptome of granulosa cells before and after ovulation triggering in the same controlled ovarian stimulation cycle. Hum Reprod. 2014 May;29(5):997-1010. doi: 10.1093/humrep/deu008. Epub 2014 Feb 7.
- Background: PubMed 24603682Haas J, Ophir L, Barzilay E, Yerushalmi GM, Yung Y, Kedem A, Maman E, Hourvitz A. GnRH agonist vs. hCG for triggering of ovulation--differential effects on gene expression in human granulosa cells. PLoS One. 2014 Mar 6;9(3):e90359. doi: 10.1371/journal.pone.0090359. eCollection 2014.
- Background: PubMed 26995658Parks JC, Patton AL, McCallie BR, Griffin DK, Schoolcraft WB, Katz-Jaffe MG. Corona cell RNA sequencing from individual oocytes revealed transcripts and pathways linked to euploid oocyte competence and live birth. Reprod Biomed Online. 2016 May;32(5):518-26. doi: 10.1016/j.rbmo.2016.02.002. Epub 2016 Feb 24.
- Background: PubMed 23856575Borgbo T, Povlsen BB, Andersen CY, Borup R, Humaidan P, Grondahl ML. Comparison of gene expression profiles in granulosa and cumulus cells after ovulation induction with either human chorionic gonadotropin or a gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2013 Oct;100(4):994-1001. doi: 10.1016/j.fertnstert.2013.05.038. Epub 2013 Jul 12.
- Background: PubMed 36857405Yu EJ, Choi WY, Park MS, Eum JH, Lee DR, Lee WS, Lyu SW, Yoon SY. RNA sequencing-based transcriptome analysis of granulosa cells from follicular fluid: Genes involved in embryo quality during in vitro fertilization and embryo transfer. PLoS One. 2023 Mar 1;18(3):e0280495. doi: 10.1371/journal.pone.0280495. eCollection 2023.
- Background: PubMed 23498999Uyar A, Torrealday S, Seli E. Cumulus and granulosa cell markers of oocyte and embryo quality. Fertil Steril. 2013 Mar 15;99(4):979-97. doi: 10.1016/j.fertnstert.2013.01.129.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cesar Lizan Tudela principal investigator
Department of Obstetrics and Gynaecology, Hospital Clínico Universitario de Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Human chorionic gonadotropin (hCG), Follitropin delta and Triptorelin in people with Low Ovarian Reserve and Poor Ovarian Response, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cesar Lizan Tudela (+34 96 197 3500, cesarlizan@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of mature oocytes (MII) (time frame: During the oocyte retrieval procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07816562, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.