NCT03555942

Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

Follicular or Luteal Start Ovarian Stimulation With Corifollitropin Alfa. A Prospective Equivalence Study With Repeated Ovarian Stimulation in Oocyte Donors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Fundacion Dexeus · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation

Detailed description

The scope of the current prospective trial is to investigate whether Luteal Stimulation (LS) results in equivalent euploid embryos with Follicular Stimulation (FS) in young reproductive age women. The use of the "oocyte donor model" allows extrapolation of the results and application of LS routinely not only in healthy women undergoing fertility preservation but also in all patients irrespective of the menstrual date. This may indeed allow widespread introduction of LS in IVF programs which may result in proper scheduling of ovarian stimulation which is a major issue in everyday clinical practice. Given that the pharmacokinetics and follicular dynamics of 150μg corifollitropin alfa for luteal stimulation has never been evaluated, the current study of luteal stimulation with corifollitropin alfa could be very interesting for several reasons: 1. Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation. 2. Fertility preservation patients for medical, oncological and non-medical indication 3. Any situation in which endometrial receptivity is not pursued.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Follicular phase corifollitropin alfa	GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
DRUG	Luteal phase corifollitropin alfa	GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)

Timeline

• Start date: 2018-05-08
• Primary completion: 2021-11-30
• Completion: 2021-12-01
• First posted: 2018-06-14
• Last updated: 2022-03-31

Locations

2 sites across 1 country: Spain