Evaluating ovarian stimulation intensity and its effect on embryo quality in older women

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 trial aims to determine whether a milder or more intense ovarian stimulation approach affects the number of euploid embryos and their morphokinetic parameters in older women undergoing preimplantation genetic testing for aneuploidy (PGT-A). Participants will receive either 20 mcg or 15 mcg of Follitropin-delta daily from day one of their cycle. The study is designed as a no-inferiority trial, meaning it seeks to show that the milder approach is not worse than the more intense one in terms of outcomes. The trial focuses on women of advanced reproductive age who are seeking fertility treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infertile patients with indication for IVF
* Undergoing preimplantation genetic screening cycles
* AMH \>= 1.5 ng/ml and \< 3.5 ng/ml (AMH result of up to one year will be valid)
* BMI 18.5 - 30 Kg/m2

Exclusion Criteria:

* Severe male factor requiring TESE (testicular sperm extraction)
* AMH \< 1.5 ng/ml or \>= 3.5 ng/ml
* Administration of any other drug potentially interfering with the treatment
* Contraindication for hormonal treatment
* Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
* Monogenic disease to be detected with PGT-M

Where it's running

• Hospital Universitario Quiron Dexeus
  Barcelona, Spain Recruiting

Study contacts

• 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.

• Reproductive outlook for women trying to conceive after medical or surgical treatment for endometriosis

  This study will try to see whether women treated medically or surgically for endometriosis are more likely to need medically assisted reproduction (PMA) and how their conception and pregnancy outcomes compare.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan, MI, Italia · NCT07437742

• Plan A male contraceptive system to block and restore sperm flow

  This test checks whether the Plan A male contraceptive system can block sperm by occluding the vas deferens and later be reversed in men seeking vasectomy-like contraception.

  Recruiting at 2 sites Phase 2 Next Life Sciences · Maribyrnong, Victoria and 2 other locations · NCT07361120

• Fertility-preserving care for endometrial cancer guided by tumor molecular type

  This trial tests whether choosing fertility-preserving medicines based on a tumor's molecular subtype helps women with early endometrial cancer keep their fertility.

  Recruiting Phase 2/3 Fudan University · Shanghai, Shanghai Municipality and 1 other locations · NCT07319429

• Surgical options to preserve ovaries when treating endometriomas

  This trial will see if different surgical methods for treating endometriomas help women who want to get pregnant have higher pregnancy and birth rates and fewer complications.

  Recruiting Clinique Tivoli Ducos · Bordeaux · NCT07119060

• Adjuvant melanoma treatments and fertility after surgery

  This project will test whether adjuvant immunotherapy or targeted MAPK inhibitor drugs affect fertility in women under 40 after melanoma surgery.

  Recruiting Intergruppo Melanoma Italiano · Bari and 9 other locations · NCT07092670

• Impact of physical activity on fertility and pregnancy outcomes in Danish couples

  This study is testing if getting more physical activity and support can help women trying to conceive have healthier pregnancies and better outcomes.

  Recruiting University of Aarhus · Aarhus · NCT06705712

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.