Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

Short name ROSE

NCTNCT02821819Other idIB012016

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Difficult recruitment

Results were posted for this trial.

This trial does not test a peptide that PepBank tracks.

Names Cetrorelix, does not test it. It appears in the summary.
Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the summary.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 15 participants (actual)
Sponsor: Instituto Bernabeu · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Spain
Start: 10 Jan 2017
Primary completion: 12 Jan 2018
Completion: 12 Jan 2018
First posted: 4 Jul 2016 (estimated)
Last update posted: 19 Aug 2019
Conditions: Infertility

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201720182019

Ph 4
ROSE
NCT02821819
10 Jan 2017 to 12 Jan 2018
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Random start ovarian stimulationOther
GonadotrophinsDrug
GnRH antagonistDrug
GnRH agonistDrug

Arms1

Experimental
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Percentage of Mature Eggs
Time frame · Up to 24 hours from the oocyte collection
Registry description
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 outcomes(1)

Fertilization Rate
Time frame · 24 hours after day of oocyte collection
Registry description
Percentage of properly fertilized eggs after microinjection (ICSI) method

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Up to 24 hours from the oocyte collection

Percentage of Mature Eggs

Group	Value (Percentage of mature eggs)	Spread
Random Start Ovarian Stimulation	82	10

Secondary and other outcome results(1)

Secondary outcomeMedian· 24 hours after day of oocyte collection

Fertilization Rate

Group	Value (Percentage of properly fertilized eggs)	Spread
Random Start Ovarian Stimulation	71	7.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Random Start Ovarian StimulationEgg-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.	0 / 15	0 / 15	0 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 35 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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