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

Phase 4

Terminated

Conditions: Infertility

Interventions: Other: Random start ovarian stimulation
Drug: Gonadotrophins
Drug: GnRH antagonist
Drug: GnRH agonist

Registration Number: NCT02821819

Lead Sponsor: Instituto Bernabeu

Brief 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 15

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Random start ovarian stimulation	GnRH antagonist	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
Random start ovarian stimulation	GnRH agonist	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
Random start ovarian stimulation	Random start ovarian stimulation	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
Random start ovarian stimulation	Gonadotrophins	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

Primary Outcome Measures

Name	Time	Method
Percentage of Mature Eggs	Up to 24 hours from the oocyte collection	When collected, eggs retain numerous cells (granulosa or cumulus cells) surrounding the oocyte; this structure is termed as the cumulus oocyte complex (COC). Few hours later (2-4 hs), the oocyte is denuded from these cumulus cells, allowing for a clearer observation of the maturity status (presence or absence of a metaphase II) of the oocyte. The percentage of mature eggs represents the proportion resulting from dividing the total number of COCs collected by the number of metaphase II oocytes and multiplied by 100.

Secondary Outcome Measures