NCT02821819

Random-start Ovarian Stimulation in Egg-donors (ROSE)

Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Instituto Bernabeu · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocyte donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.

Detailed description

The study group will start ovarian stimulation randomly in different moments throughout the menstrual cycle. Randomization will take place on day 2-3 of the menstrual cycle, according to a list of random allocation of treatments and egg-donors will be assigned to random start ovarian stimulation: During follicular phase starting at day 5,7,9,11 or 13 of the menstrual cycle and during luteal phase starting at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. Egg-donors will receive urinary follicle stimulating hormone (FSH) 150-225 IU/d in gonadotropin-releasing hormone (GnRH) antagonist protocol with cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation and a GnRH agonist trigger with triptorelin 0,2 mg to induce the final follicular maturation. Transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	Random start ovarian stimulation	Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
DRUG	Gonadotrophins	Urinary FSH 150-225 IU/d
DRUG	GnRH antagonist	Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
DRUG	GnRH agonist	GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.

Timeline

• Start date: 2017-01-10
• Primary completion: 2018-01-12
• Completion: 2018-01-12
• First posted: 2016-07-04
• Last updated: 2019-08-19
• Results posted: 2019-08-19

Locations

1 site across 1 country: Spain