AuthorisedTherapeutic use (Phase IV)Interventional

The impact of ovarian stimulation with hMG on embryo quality in advanced age women. A randomized controlled trial

As women get older, having a baby through IVF can become more difficult because egg quality and numbers naturally decline. During IVF, hormone injections encourage the ovaries to grow several eggs at once. This clinical trial is comparing two slightly different recipes of these fertility medicines in women of advanced reproductive age. Participants will be placed into one of two groups. Each group receives a different balance of two standard fertility drugs: follitropin delta (Rekovelle) and human menopausal gonadotrophin (Menopur). Researchers will follow the treatment cycle to see which combination leads to better egg collection numbers, healthier embryo development in the laboratory, and higher pregnancy rates. Both medicines are already widely used in fertility care. The goal is to learn how to tailor hormone doses to give older women the best possible chance of having a baby.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Santiago Dexeus Font Fundacio Privada

Enrolment target

240

Start

23 Jun 2026

infertility

What is this study about?

For many women trying to start or grow a family later in life, fertility treatments such as IVF (in vitro fertilisation) offer valuable support. However, as women get older, both the number and quality of their eggs naturally decrease. In standard IVF, daily hormone injections stimulate the ovaries to produce multiple mature eggs. Finding the exact balance of these hormones is key to collecting healthy eggs that can be fertilised into strong embryos.

This study looks closely at two well-established fertility medications: follitropin delta and human menopausal gonadotrophin (hMG). Both drugs encourage egg growth, but they work in slightly different ways. By comparing two specific dosing combinations, doctors hope to see if shifting the balance between these two medicines creates better conditions for egg development in older women.

During the trial, scientists will track how embryos develop hour by hour in the laboratory using specialised monitoring techniques. They will check how many eggs fertilise, how smoothly the cells divide, and how many develop into high-quality embryos suitable for transfer or freezing. They will also look at final pregnancy and birth rates.

Ultimately, this research matters because it could help doctors fine-tune IVF protocols for women of advanced reproductive age. Personalising hormone treatments may improve the chances of a successful, healthy pregnancy while reducing the emotional and physical strain of repeated, unsuccessful cycles.

Key takeaways

Compares two different hormone dosage mixtures during an IVF cycle.
Aimed at women of advanced reproductive age hoping to improve embryo quality.
Uses approved fertility medications alongside close ultrasound and blood test monitoring.
Tracks egg growth, laboratory embryo development, and early pregnancy rates.
Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

This trial is designed for adult women who are having fertility treatment and need ovarian stimulation as part of their IVF care. The study focuses specifically on women of advanced reproductive age who are hoping to improve their chances of producing healthy embryos.

To take part, you must be 18 or older and planning an IVF cycle using a specific method called a PPOS protocol (progestin-primed ovarian stimulation). This protocol uses oral progesterone capsules to prevent early ovulation instead of traditional daily injections.

Your fertility clinic team will check your overall medical history, ovarian reserve, and hormone levels to make sure this trial is safe and appropriate for your individual circumstances. Women with certain medical conditions or those using different IVF protocols may not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a female aged 18 or older.
I am planning to undergo an IVF cycle with ovarian stimulation.
I am considered to be of advanced reproductive age by my fertility team.
I am suitable for an IVF cycle using progestin to prevent early ovulation (a PPOS cycle).
I am able to attend regular clinic appointments for injections, blood tests, and scans.

Answer every question to see your result.

What does participation involve?

If you join the trial, your care will follow a typical IVF schedule with close medical tracking. You will be randomly assigned to receive one of two specific daily hormone injection combinations to stimulate your ovaries. Alongside these, you will take oral capsules to stop your body from releasing eggs too early. During the stimulation phase, which usually lasts around 8 to 14 days, you will have regular clinic visits for blood tests and ultrasound scans to monitor your ovaries. Once your eggs are ready, you will have a 'trigger' injection followed by a short egg collection procedure under light sedation. In the laboratory, your eggs will be fertilised, and the resulting embryos will be carefully monitored as they grow. If embryos reach the blastocyst stage, they may be frozen for future transfer. If an embryo is transferred, you will be followed up with pregnancy tests and early ultrasounds around weeks 8 to 10. Overall, your direct involvement will span from the start of your stimulation cycle through to the early stages of any resulting pregnancy.

Potential risks and benefits

Taking part may not give you any personal medical benefit over standard IVF care, but the close monitoring could help you and your clinic learn more about how your body responds to treatment. The results could also help improve IVF care for other women in the future. The risks are similar to those of standard IVF, including temporary bloating, pelvic discomfort, bruising from injections, mood swings, or rarely, ovarian hyperstimulation syndrome (OHSS). You are entirely free to withdraw from the study at any time without giving a reason, and your regular NHS or private fertility care will not be affected in any way.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is the main goal of this trial?

The trial aims to find out which of two hormone medicine combinations works best to produce high-quality embryos for women of advanced reproductive age undergoing IVF.

Are the medications being tested safe and approved?

Yes. The medications used (such as Rekovelle and Menopur) are already approved and routinely used in fertility clinics. This trial compares different dosage balances of these trusted treatments.

How will I be assigned to a treatment group?

You will be placed into one of the two groups at random, like flipping a coin. This helps ensure the comparison between the two medication doses is completely fair and accurate.

Will taking part guarantee a successful pregnancy?

No clinical trial can guarantee pregnancy. The study aims to discover which approach offers the best chances, but individual outcomes vary depending on many personal factors.

Can I leave the study if I change my mind?

Yes, absolutely. Joining is entirely voluntary. You can stop participating at any point, and your ongoing medical care will continue as normal.