Dual Trigger for Elective Fertility Preservation

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The widespread availability of efficient contraception as well as women's increased education has led to childbearing postponement. Combined with the increased recognition of the concept of "ovarian aging", this has opened the Pandora´s box of EOC, which is currently considered a safe and cost-efficient approach among assisted reproduction techniques.

Previous studies have shown that two main factors determine the CLBR after EOC: 1) patient's age at the time of oocyte banking, and 2) the number of oocytes retrieved. Therefore, measures aiming at increasing the oocyte yield, specially the number of mature oocytes retrieved, will maximize the success of this technique.

In the last few years, the dual trigger for final oocyte maturation has emerged has an approach that seems to improve both oocyte yield and quality when compared to the hCG trigger alone. Nowadays, the standard of care in EOC patients is final oocyte maturation with a single bolus of GnRH-a. Understanding the impact of the dual trigger on the number of MII oocytes retrieved in patients undergoing EOC will improve the treatment protocols and allow for a better patient counselling.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Santiago Dexeus Font
• Treatments: Prolactin Release-Inhibiting Factors

Criteria

Inclusion Criteria:

• Able and willing to sign the Patient Consent Form and adhere to study visitation schedule

• antral follicle count (AFC) <20

• Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)

• Age >=18 and ≤40 years

• BMI >18 and <30 kg/m2

Exclusion Criteria:

• Medically indicated fertility preservation

• AFC ≥ 20

• Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria

• FSH ≥ 20

• History of untreated autoimmune, endocrine or metabolic disorders

• 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).