Trial Outcomes & Findings for Random-start Ovarian Stimulation in Egg-donors (ROSE) (NCT NCT02821819)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

Up to 24 hours from the oocyte collection

Results posted on

2019-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	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 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 Gonadotrophins: Urinary FSH 150-225 IU/d GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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 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 Gonadotrophins: Urinary FSH 150-225 IU/d GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Random Start Ovarian Stimulation n=14 Participants 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 LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later 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 Gonadotrophins: Urinary FSH 150-225 IU/d GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Age, Continuous	25.2 years STANDARD_DEVIATION 4.2 • n=14 Participants
Sex: Female, Male Female	14 Participants n=14 Participants
Sex: Female, Male Male	0 Participants n=14 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Random Start Ovarian Stimulation n=15 Participants 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 LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later 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 Gonadotrophins: Urinary FSH 150-225 IU/d GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Percentage of Mature Eggs	82 Percentage of mature eggs Standard Deviation 10

SECONDARY outcome

Timeframe: 24 hours after day of oocyte collection

Percentage of properly fertilized eggs after microinjection (ICSI) method

Outcome measures

Outcome measures
Measure	Random Start Ovarian Stimulation n=14 Participants 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 LH peak +3,+5,+7,+9 or +11. They will receive urinary FSH 150-225 IU/d and five days later 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 Gonadotrophins: Urinary FSH 150-225 IU/d GnRH antagonist: Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation GnRH agonist: GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Fertilization Rate	71 Percentage of properly fertilized eggs Standard Deviation 7.8

Adverse Events

Random Start Ovarian Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Juan Carlos Castillo

Instituto Bernabeu

Phone: +34650562634

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place