One shot instead of many: new egg donor study aims to ease treatment burden

NCT ID NCT06193135

Disease control Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares a single injection of corifollitropin alfa (Elonva) to daily shots of follitropin beta (Puregon) for ovarian stimulation in egg donors. Both groups also take medroxyprogesterone acetate to prevent early ovulation. The goal is to see if the simpler one-shot approach yields a similar number of mature eggs while reducing the physical and emotional strain of daily injections. The trial enrolls 318 healthy women aged 18–35 who are egg donors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: corifollitropin alfa (Elonva) and follitropin beta (Puregon)
What this could lead to: If it works, this could simplify ovarian stimulation for egg donors, reducing the number of injections and easing the physical and emotional burden of treatment.
What could go wrong: This is a mid-sized trial (318 participants) comparing two established drugs, so the main risk is that the single-shot approach may not produce as many usable eggs as daily injections, or may cause similar side effects like bloating or ovarian hyperstimulation.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 318 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

female infertility infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility, female Reproductive sterility

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

One shot instead of many: new egg donor study aims to ease treatment burden

What the study statuses mean