Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA) (TROPIX)

September 9, 2025 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

318

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46015
        • Recruiting
        • IVI Valencia
        • Contact:
        • Principal Investigator:
          • JUAN GILES, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Elonva
Patients will undergo controlled ovarian stimulation with Corifolitropin α (Elonva), 100-150 micrograms (100 in< 60kg and 150 ≥ 60 kg) + Progevera 10 mg.
Drug: Corifolitropin Alfa
Patients will receive a single dose of Colifolitropin alfa, then will receive daily dose of Folitropin Beta since triggering criteria are met.
Other Names:
  • ELONVA
Active Comparator: Puregon
Patients will undergo controlled ovarian stimulation with Folitropin β (Puregon) + Progevera 10 mg.
Drug: Folitropin Beta
Patient will receive daily dose of Folitropin Beta since triggering criteria are met.
Other Names:
  • PUREGON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Time Frame: 2 years
Quantification of total oocytes in metaphase II
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of early luteinization
Time Frame: 2 years
Quantification of cycle cancellation due to lack of response and failure to obtain MII oocytes in puncture.
2 years
Controlled ovraian stimulation duration
Time Frame: 2 years
Quantification of total days of estimulation
2 years
Total cost of each stimulation type.
Time Frame: 2 years
Quantification of cost.
2 years
Medication tolerance: pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS), etc.
Time Frame: 2 years
Quantification of pain, abdominal distension, ovarian hyperstimulation syndrome (OHSS) using a specifically designed questionarie for this strudy.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2304-VLC-051-JG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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