Infertility, FemaleTROPIXNCT06193135
Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)
A study testing Corifolitropin Alfa and Folitropin Beta in people with Infertility, Female and Reproductive Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites in Spain.
Trial summary
IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Female, Reproductive Sterility
- What is being tested?
- Corifolitropin Alfa and Folitropin Beta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Jul 2025to 31 Dec 2025
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signature of the subject's informed consent prior to any trial-related activity.
- Age between 18 and 35 years (both inclusive).
- Regular menstrual cycle, from 25 to 35 days (both inclusive).
- Absence of physical and psychological illness at the time of donation at the discretion of the investigator.
- BMI 18-28 kg/m2 (both inclusive) at the time of donation.
- No personal or family history of interest at the discretion of the investigator.
Show all 12Show fewer
- Normal uterus and ovaries, without organic pathology.
- No polycystic ovaries.
- Antral follicle count greater than 12 in the sum of the two ovaries at the time of the screening visit.
- Normal karyotype.
- Negative infectious disease screening (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis).
- General analysis with hemogram, hemostasis and biochemistry with parameters within normality.
Who cannot join
- Concurrent participation in another clinical trial.
- Previous participation in this clinical trial.
- Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment.
- Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins.
- Personal history of thrombophlebitis and thromboembolic phenomena and hypertension.
- Severe hepatic insufficiency, cardiovascular disease
Show all 9Show fewer
- Suspicion or evidence of breast malignancy or hormone-dependent genital organs.
- Known hypersensitivity to AMP or its excipients
- Any reason for exclusion from the oocyte donation program.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
IVI Valencia
Valencia, Valencia, 46015
Juan Giles, MDPhD, juan.giles@ivirma.com
Laura Caracena, Mrs, laura.caracena@ivirma.com
- Recruiting
Ivi Valencia
Valencia, Valencia, 46015
Laura Caracena, Study Coordinator, +34 687031978, laura.caracena@ivirma.com
JUAN GILES, PhD
About this study
IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. One of the phases of the treatment that contributes most to this situation is ovarian stimulation; as it involves the administration of daily injections which, in addition to the discomfort of administration, causes anxiety to the patient about its correct administration and possible side effects and to physicians concerns about patient compliance.
Advances in pharmacology and knowledge of ovarian pathophysiology have led to the development of new protocols that simplify and reduce drug administration, decrease the potential risk of misapplication and contribute to an improved patient experience. In this context, Corifollitropin α, a long-acting recombinant FSH (rFSH) molecule, provides with a single subcutaneous injection similar results as daily administration of rFSH during a week.
Read more
On the other hand, conventional stimulation protocols used in ART resort to using a GnRH analogue (agonist or antagonist) to prevent early luteinization, which is defined as the presence of a progesterone value of > 1.5 ng/ml on the day of induced ovulation. Nevertheless, its use presents some disadvantages, such as it being sometimes complex to achieve desensitization or consistent hypothalamic block, risk of OHS when ovulation is triggered with HCG or its cost. Hence the interest in exploring new options to prevent a premature peak in LH. Nowadays, the oral administration of progestagens (progesterone-primed ovarian stimulation [PPOS]) during the follicular phase of ovarian stimulation (OS) has emerged as an attractive alternative to conventional protocols for preventing early luteinization. Moreover, PPOS produces a similar or even better, in some subgroups, response to OS (length of treatment, number of MII, cancelation rate, etc.), reproductive outcomes (pregnancy rate, live birth rate, etc) and safety (rate of ovarian hyperstimulation [OHSS] or congenital malformations).
Thus, PPOS would seem to be an effective option for personalized protocols, particularly when fresh embryo transfer (FET) is not to be performed, a circumstance that is likely to rise in frequency given the progressive increase in women's age at childbearing; for example, in oocyte donation, or in fertility preservation (FP) and preimplantation genetic testing for aneuploidy (PGT-A). However, very little data are available regarding cycle outcome following Corifollitropin α and PPOS as pituitary suppressor.
The present study, a prospective RCT, was designed to evaluate cycle characteristics (MII oocytes as the primary objective) and endocrinologic profiles of oocyte donors receiving Corifollitropin α and MPA as co-treatment compared with those receiving a daily dose of rFSH (follitropin β) as a control.
- Conditions
- Infertility, Female, Reproductive Sterility
- Being tested
- Corifolitropin Alfa, Folitropin Beta
- Keywords
- Oocyte donation, Corifolitropin alpha, Premature luteinization, Medroxiprogesterone acetate, Controlled ovarian estimulation, Folitropin beta
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corifolitropin AlfaDrug
Also called ELONVA
Patients will receive a single dose of Colifolitropin alfa, then will receive daily dose of Folitropin Beta since triggering criteria are met.
Folitropin BetaDrug
Also called PUREGON
Patient will receive daily dose of Folitropin Beta since triggering criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Elonva | Experimental | Patients will undergo controlled ovarian stimulation with Corifolitropin α (Elonva), 100-150 micrograms (100 in< 60kg and 150 ≥ 60 kg) + Progevera 10 mg. Receives: Drug: Corifolitropin Alfa |
| Puregon | Active comparator | Patients will undergo controlled ovarian stimulation with Folitropin β (Puregon) + Progevera 10 mg. Receives: Drug: Folitropin Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the number of total oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.
Number of total oocytes and oocytes metaphase II
Measured: 2 years
To compare the number of metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.
Quantification of total oocytes in metaphase II
Measured: 2 years
Secondary outcomes (4)
Incidence of early luteinization
Quantification of cycle cancellation due to lack of response and failure to obtain MII oocytes in puncture.
Measured: 2 years
Medication tolerance: pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS), etc.
Quantification of pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS) using a specifically designed questionarie for this strudy.
Measured: 2 years
Controlled ovraian stimulation duration
Quantification of total days of estimulation
Measured: 2 years
Total cost of each stimulation type.
Quantification of cost.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start8 Jul 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, open-label, parallel-group, low-intervention, single-center clinical trial.
- Masking
- None (open label)
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193135
- Sponsor's protocol ID
- 2304-VLC-051-JG
- Acronym
- TROPIX
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2023
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalfoglou AL. Navigating conflict of interest in oocyte donation. Am J Bioeth. 2001 Fall;1(4):W1. doi: 10.1162/152651601317139333. No abstract available.
PubMed 12858870Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.
PubMed 23352098Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28.
PubMed 20483664Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.
PubMed 26003273
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA)
- ClinicalTrials.gov ID
- NCT06193135
- Acronym / sponsor ID
- TROPIX / 2304-VLC-051-JG
- Conditions
- Infertility, Female, Reproductive Sterility
- Keywords
- Oocyte donation, Corifolitropin alpha, Premature luteinization, Medroxiprogesterone acetate, Controlled ovarian estimulation, Folitropin beta
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
IVF patients frequently experience physical, emotional or physicological burden; this is particularly relevant in the case of oocyte donors, since young women undergo a procedure that is of no health benefit to them. One of the phases of the treatment that contributes most to this situation is ovarian stimulation; as it involves the administration of daily injections which, in addition to the discomfort of administration, causes anxiety to the patient about its correct administration and possible side effects and to physicians concerns about patient compliance.
Advances in pharmacology and knowledge of ovarian pathophysiology have led to the development of new protocols that simplify and reduce drug administration, decrease the potential risk of misapplication and contribute to an improved patient experience. In this context, Corifollitropin α, a long-acting recombinant FSH (rFSH) molecule, provides with a single subcutaneous injection similar results as daily administration of rFSH during a week.
On the other hand, conventional stimulation protocols used in ART resort to using a GnRH analogue (agonist or antagonist) to prevent early luteinization, which is defined as the presence of a progesterone value of > 1.5 ng/ml on the day of induced ovulation. Nevertheless, its use presents some disadvantages, such as it being sometimes complex to achieve desensitization or consistent hypothalamic block, risk of OHS when ovulation is triggered with HCG or its cost. Hence the interest in exploring new options to prevent a premature peak in LH. Nowadays, the oral administration of progestagens (progesterone-primed ovarian stimulation [PPOS]) during the follicular phase of ovarian stimulation (OS) has emerged as an attractive alternative to conventional protocols for preventing early luteinization. Moreover, PPOS produces a similar or even better, in some subgroups, response to OS (length of treatment, number of MII, cancelation rate, etc.), reproductive outcomes (pregnancy rate, live birth rate, etc) and safety (rate of ovarian hyperstimulation [OHSS] or congenital malformations).
Thus, PPOS would seem to be an effective option for personalized protocols, particularly when fresh embryo transfer (FET) is not to be performed, a circumstance that is likely to rise in frequency given the progressive increase in women's age at childbearing; for example, in oocyte donation, or in fertility preservation (FP) and preimplantation genetic testing for aneuploidy (PGT-A). However, very little data are available regarding cycle outcome following Corifollitropin α and PPOS as pituitary suppressor.
The present study, a prospective RCT, was designed to evaluate cycle characteristics (MII oocytes as the primary objective) and endocrinologic profiles of oocyte donors receiving Corifollitropin α and MPA as co-treatment compared with those receiving a daily dose of rFSH (follitropin β) as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, open-label, parallel-group, low-intervention, single-center clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Elonva | Experimental | Drug: Corifolitropin AlfaPatients will undergo controlled ovarian stimulation with Corifolitropin α (Elonva), 100-150 micrograms (100 in< 60kg and 150 ≥ 60 kg) + Progevera 10 mg. |
| Puregon | Active comparator | Drug: Folitropin BetaPatients will undergo controlled ovarian stimulation with Folitropin β (Puregon) + Progevera 10 mg. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Signature of the subject's informed consent prior to any trial-related activity.
- Age between 18 and 35 years (both inclusive).
- Regular menstrual cycle, from 25 to 35 days (both inclusive).
- Absence of physical and psychological illness at the time of donation at the discretion of the investigator.
- BMI 18-28 kg/m2 (both inclusive) at the time of donation.
Key exclusion criteria (9 listed)
- Concurrent participation in another clinical trial.
- Previous participation in this clinical trial.
- Use of long-term hormonal contraception (hormonal IUD or subcutaneous implants) at least 1 month prior to enrollment.
- Any systemic or metabolic disorder (i.e.: diabetes...) that contraindicates the use of gonadotropins.
- Personal history of thrombophlebitis and thromboembolic phenomena and hypertension.
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 |
|---|---|---|
| Corifolitropin AlfaAlso: ELONVAPatients will receive a single dose of Colifolitropin alfa, then will receive daily dose of Folitropin Beta since triggering criteria are met. | Drug | Elonva |
| Folitropin BetaAlso: PUREGONPatient will receive daily dose of Folitropin Beta since triggering criteria are met. | Drug | Puregon |
Primary outcome
To compare the number of total oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.
Time frame: 2 years
Number of total oocytes and oocytes metaphase II
To compare the number of metaphase II (MII) oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization.
Time frame: 2 years
Quantification of total oocytes in metaphase II
4 secondary outcomes
Incidence of early luteinization
Time frame: 2 years
Medication tolerance: pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS), etc.
Time frame: 2 years
Controlled ovraian stimulation duration
Time frame: 2 years
Total cost of each stimulation type.
Time frame: 2 years
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 15 Sep 2025.
- Results publication: PubMed 12858870Kalfoglou AL. Navigating conflict of interest in oocyte donation. Am J Bioeth. 2001 Fall;1(4):W1. doi: 10.1162/152651601317139333. No abstract available.
- Results publication: PubMed 23352098Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.
- Results publication: PubMed 20483664Corifollitropin alfa Ensure Study Group. Corifollitropin alfa for ovarian stimulation in IVF: a randomized trial in lower-body-weight women. Reprod Biomed Online. 2010 Jul;21(1):66-76. doi: 10.1016/j.rbmo.2010.03.019. Epub 2010 Mar 28.
- Results publication: PubMed 26003273Boostanfar R, Shapiro B, Levy M, Rosenwaks Z, Witjes H, Stegmann BJ, Elbers J, Gordon K, Mannaerts B; Pursue investigators. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015 Jul;104(1):94-103.e1. doi: 10.1016/j.fertnstert.2015.04.018. Epub 2015 May 21.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corifolitropin Alfa and Folitropin Beta in people with Infertility, Female and Reproductive Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 2 sites 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 12 inclusion and 9 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 JUAN GILES, PhD (+34 963.05.90.00, juan.giles@ivirma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the number of total oocytes obtained after controlled ovarian stimulation with α-Corifolitropin vs. β-Folitropin in donors in whom medroxyprogesterone acetate (MPA) was used to prevent early luteinization. (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT06193135, which also lists 4 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 15 Sep 2025.