search
Back to results

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

Primary Purpose

Infertility

Status
Terminated
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Random start ovarian stimulation
Gonadotrophins
GnRH antagonist
GnRH agonist
Sponsored by
Instituto Bernabeu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ovarian stimulation, random, egg donation, antagonist, gnrh agonist trigger

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Instituto Bernabeu

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Random start ovarian stimulation

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Fertilization Rate
Percentage of properly fertilized eggs after microinjection (ICSI) method

Full Information

First Posted
June 19, 2016
Last Updated
July 11, 2019
Sponsor
Instituto Bernabeu
search

1. Study Identification

Unique Protocol Identification Number
NCT02821819
Brief Title
Random-start Ovarian Stimulation in Egg-donors (ROSE)
Acronym
ROSE
Official Title
Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult recruitment
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
January 12, 2018 (Actual)
Study Completion Date
January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Bernabeu

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovarian stimulation, random, egg donation, antagonist, gnrh agonist trigger

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Random start ovarian stimulation
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Random start ovarian stimulation
Other Intervention Name(s)
Ovarian stimulation
Intervention Description
Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
Intervention Type
Drug
Intervention Name(s)
Gonadotrophins
Other Intervention Name(s)
Ovarian stimulation
Intervention Description
Urinary FSH 150-225 IU/d
Intervention Type
Drug
Intervention Name(s)
GnRH antagonist
Other Intervention Name(s)
Ovarian stimulation
Intervention Description
Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
Final follicular maturation
Intervention Description
GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Primary Outcome Measure Information:
Title
Percentage of Mature Eggs
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.
Time Frame
Up to 24 hours from the oocyte collection
Secondary Outcome Measure Information:
Title
Fertilization Rate
Description
Percentage of properly fertilized eggs after microinjection (ICSI) method
Time Frame
24 hours after day of oocyte collection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan C Castillo, Md. PhD.
Organizational Affiliation
Instituto Bernabeu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Bernabeu
City
Alicante
ZIP/Postal Code
03016
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.institutobernabeu.com
Description
Setting
URL
http://www.ncbi.nlm.nih.gov/pubmed/27114329
Description
Reference

Learn more about this trial

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

We'll reach out to this number within 24 hrs