Intranasal Nafarelin to Trigger Final Egg M maturation in Fertility Preservation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, non-inferiority trial compares intranasal nafarelin with subcutaneous triptorelin to trigger final oocyte maturation in women undergoing fertility preservation with oocyte cryopreservation. Participants are adults meeting specific fertility preservation criteria and undergoing progesterone-primed ovarian stimulation. The primary outcome is the number of mature oocytes (MII) retrieved, with a non-inferiority margin of 2 oocytes, 80% power, and a two-sided alpha of 0.05. Subcutaneous triptorelin serves as the control, while intranasal nafarelin is the experimental trigger. The study is conducted at multiple sites affiliated with Fundacion Dexeus in Spain.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women undergoing fertility preservation cycles with oocyte cryopreservation
* Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)
* BMI 18 - 30 kg/m2

Exclusion Criteria:

* Allergy or hypersensitivity to either of the study drugs
* Hypopituitarism
* Known pituitary tumour
* Contraindication to intranasal medication administration
* Previous poor response to agonist trigger

Where it's running

• Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
  Barcelona, Spain Recruiting
• Dexeus Mujer Sabadell
  Sabadell, Barcelona, Spain Not yet recruiting
• Dexeus Mujer Sant Cugat
  Sant Cugat del Vallès, Barcelona, Spain Not yet recruiting
• Dexeus Mujer Reus
  Reus, Tarragona, Spain Not yet recruiting
• Dexeus Mujer Tarragona
  Tarragona, Spain Not yet recruiting

Study contacts

• Principal investigator: Nikolaos P Polyzos, MD, PhD — Dexeus Fertility
• Study coordinator: Nikolaos P Polyzos, MD, PhD
• Email: nikpol@dexeus.com
• Phone: 0034932274700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Follicular Flushing During Abdominal Egg Retrieval in Women with Low Egg Reserve

  This study tests whether rinsing the egg sacs during abdominal egg collection yields more eggs and more mature eggs for freezing in women with low ovarian reserve.

  Recruiting at 2 sites Centrum Clinic IVF Center · Ankara, Ankara and 1 other locations · NCT07877025

• GnRH agonist versus dual hCG/GnRH trigger for ovulation induction in fertility preservation

  We will test whether using a GnRH agonist alone or a dual trigger (GnRH agonist plus hCG) gives better egg retrieval numbers and safety for people with cancer doing egg freezing before gonadotoxic treatment.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna · NCT07546136

• Combining ovarian tissue freezing with egg (oocyte) freezing versus egg freezing alone

  This research will test whether combining ovarian tissue freezing with egg freezing helps adult women with cancer preserve more fertility than egg freezing alone.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Bologna · NCT07546123

• Long-term follow-up of fertility preservation in women after cancer remission

  This project will see how fertility preservation options work long-term for women in remission from cancer or hematological disease, including how often preserved material is used and the psychological effects.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07312058

• When to start hormones after stopping combined birth control for planned egg freezing

  This trial tests whether taking a two-month break from combined hormonal birth control versus starting ovarian stimulation immediately affects outcomes for ovary-bearing people aged 18–40 who are planning to freeze their eggs.

  Recruiting at 2 sites Shady Grove Fertility Reproductive Science Center · Orange, Connecticut and 2 other locations · NCT07225660

• Fertility-preserving hysteroscopic treatment outcomes for endometrial cancer and atypical hyperplasia

  This project tests whether removing lesions by hysteroscopy combined with hormonal therapy helps women with endometrial cancer or atypical hyperplasia preserve fertility and achieve good pregnancy and cancer-control outcomes.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07077876

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.