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

Instituto Bernabeu

Status and phase: Terminated; Phase 4

Conditions: Infertility

Treatments: Drug: Gonadotrophins; Other: Random start ovarian stimulation; Drug: GnRH agonist; Drug: GnRH antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT02821819

IB012016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Premenopausal women
• 18-35 years old
• FSH levels < 10 IU/liter
• Antral follicle count (AFC) > 10
• Regular cycles
• Body Mass Index (BMI) < 28
• Signed informed consent

Exclusion criteria

• Polycystic ovary syndrome (PCOS) patients
• Allergy to gonadotrophins
• Concomitant participation in other trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

Random start ovarian stimulation

Experimental group

Description:

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 at luteinizing hormone (LH) peak +3,+5,+7,+9 or +11. They will receive urinary follicle stimulating hormone (FSH) 150-225 International units / daily (IU/d) and five days later the gonadotropin-releasing hormone (GnRH) antagonist: cetrorelix acetate 0,25 mg/d will be added until achieving criteria for receiving triptorelin 0,2 mg to induce final follicular maturation. Egg collection will take place 36 hours later. Interventions: * Random start ovarian stimulation * Gonadotrophins: Urinary FSH 150-225 IU/d * GnRH antagonists: Cetrorelix 0,25 mg/d * GnRH agonist for triggering: Triptorelin 0,2 mg single dose

Treatment:

Drug: GnRH antagonist

Drug: GnRH agonist

Other: Random start ovarian stimulation

Drug: Gonadotrophins