InfertilityPhase 4ROSENCT02821819
Random-start Ovarian Stimulation in Egg-donors (ROSE)
A Phase 4 study testing Random start ovarian stimulation, Gonadotrophins and GnRH antagonist in people with Infertility, run by Instituto Bernabeu at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Random start ovarian stimulation, Gonadotrophins and GnRH antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2017to 12 Jan 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Polycystic ovary syndrome (PCOS) patients
- Allergy to gonadotrophins
- Concomitant participation in other trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
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.
Read the 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
- Being tested
- Random start ovarian stimulation, Gonadotrophins, GnRH antagonist, GnRH agonist
- Keywords
- ovarian stimulation, random, egg donation, antagonist, gnrh agonist trigger
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Random start ovarian stimulationOther
Also called Ovarian stimulation
Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
GonadotrophinsDrug
Also called Ovarian stimulation
Urinary FSH 150-225 IU/d
GnRH antagonistDrug
Also called Ovarian stimulation
Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
GnRH agonistDrug
Also called Final follicular maturation
GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
| Study group | Role | What they receive |
|---|---|---|
| Random start ovarian stimulation | Experimental | 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 Receives: Other: Random start ovarian stimulation; Drug: Gonadotrophins; Drug: GnRH antagonist; Drug: GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Mature Eggs
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.
Measured: Up to 24 hours from the oocyte collection
Secondary outcomes (1)
Fertilization Rate
Percentage of properly fertilized eggs after microinjection (ICSI) method
Measured: 24 hours after day of oocyte collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study start10 Jan 2017
- Primary completion12 Jan 2018
- Study completion12 Jan 2018
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Carlos Castillo, Instituto Bernabeu
- Investigators
- Juan C Castillo, Md. PhD., Principal investigator, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821819
- Sponsor's protocol ID
- IB012016
- Acronym
- ROSE
- Status last verified
- Jul 2019
- First submitted
- 19 Jun 2016
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
- ClinicalTrials.gov ID
- NCT02821819
- Acronym / sponsor ID
- ROSE / IB012016
- Conditions
- Infertility
- Keywords
- ovarian stimulation, random, egg donation, antagonist, gnrh agonist trigger
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 12 Jan 2018 (actual)
- Study completion
- 12 Jan 2018 (actual)
- First posted
- 4 Jul 2016 (estimated)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Random start ovarian stimulation | Experimental | Other: Random start ovarian stimulation, Drug: Gonadotrophins, Drug: GnRH antagonist, Drug: GnRH agonistEgg-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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Premenopausal women
- 18-35 years old
- FSH levels < 10 IU/liter
- Antral follicle count (AFC) > 10
- Regular cycles
Key exclusion criteria (3 listed)
- Polycystic ovary syndrome (PCOS) patients
- Allergy to gonadotrophins
- Concomitant participation in other trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Random start ovarian stimulationAlso: Ovarian stimulationEgg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle. | Other | Random start ovarian stimulation |
| GonadotrophinsAlso: Ovarian stimulationUrinary FSH 150-225 IU/d | Drug | Random start ovarian stimulation |
| GnRH antagonistAlso: Ovarian stimulationCetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation | Drug | Random start ovarian stimulation |
| GnRH agonistAlso: Final follicular maturationGnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation. | Drug | Random start ovarian stimulation |
Primary outcome
Percentage of Mature Eggs
Time frame: 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.
1 secondary outcome
Fertilization Rate
Time frame: 24 hours after day of oocyte collection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SettingLink provided by the sponsor.
- ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan C Castillo, Md. PhD. principal investigator
Instituto Bernabeu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Random start ovarian stimulation, Gonadotrophins and GnRH antagonist in people with Infertility, run by Instituto Bernabeu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Mature Eggs (time frame: Up to 24 hours from the oocyte collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.