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

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ClinicalTrials.gov Identifier: NCT02821819
Recruitment Status : Recruiting
First Posted : July 4, 2016
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Juan Carlos Castillo, Instituto Bernabeu

Brief Summary:
The purpose of this prospective single-center study is to evaluate the laboratory outcome after random start ovarian stimulation in oocytes donors. The study will be performed in egg-donors but this type of treatment has the potential to be implemented in general infertility population.

Condition or disease Intervention/treatment Phase
Infertility Other: Random start ovarian stimulation Drug: Gonadotrophins Drug: GnRH antagonist Drug: GnRH agonist Phase 4

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 LH peak +3,+5,+7,+9 or +11.

Egg-donors will receive urinary FSH 150-225 IU/d in antagonist protocol cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation + GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation. Foliculometry by transvaginal ultrasound and serum analysis (estradiol, progesterone, LH and FSH) will be included for cycle monitoring.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
Actual Study Start Date : January 10, 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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 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 UI/d
  • GnRH antagonists: Cetrorelix 0,25 mg/d
  • GnRH agonist for triggering: Triptorelin 0,2 mg single dose
Other: Random start ovarian stimulation
Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
Other Name: Ovarian stimulation

Drug: Gonadotrophins
Urinary FSH 150-225 IU/d
Other Name: Ovarian stimulation

Drug: GnRH antagonist
Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
Other Name: Ovarian stimulation

Drug: GnRH agonist
GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Other Name: Final follicular maturation




Primary Outcome Measures :
  1. Number of mature eggs [ Time Frame: Up to 24 hours from the oocyte collection ]
    Rate of mature eggs / total eggs


Secondary Outcome Measures :
  1. Fertilization rate [ Time Frame: 24 hours after day of oocyte collection ]
    Fertilization rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Premenopausal women
  • 18-35 years old
  • FSH levels < 10 mIU/ml
  • AFC> 10
  • Regular cycles
  • BMI < 28
  • Signed informed consent

Exclusion Criteria:

  • PCOS patients
  • Allergy to gonadotrophins
  • Concomitant participation in other trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02821819


Contacts
Contact: Juan C Castillo, Md. PhD. +34 965 154 000 jcastillo@institutobernabeu.com

Locations
Spain
Instituto Bernabeu Recruiting
Alicante, Spain, 03016
Contact: Juan C Castillo, Md. PhD.         
Sponsors and Collaborators
Instituto Bernabeu
Investigators
Principal Investigator: Juan C Castillo, Md. PhD. Instituto Bernabeu

Additional Information:
Responsible Party: Juan Carlos Castillo, Md. PHd., Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT02821819     History of Changes
Other Study ID Numbers: IB012016
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Juan Carlos Castillo, Instituto Bernabeu:
ovarian stimulation
random
egg donation
antagonist
gnrh agonist trigger

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Prolactin Release-Inhibiting Factors
Cetrorelix
Deslorelin
Triptorelin Pamoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Fertility Agents, Female
Fertility Agents
Hormone Antagonists