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

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.

Study Overview

• Status: Terminated
• Conditions: Infertility
• Intervention / Treatment: Other: Random start ovarian stimulation; Drug: Gonadotrophins; Drug: GnRH antagonist; Drug: GnRH agonist

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Instituto Bernabeu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 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

Other: Random start ovarian stimulation; Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.; Other Names: Ovarian stimulation; Drug: Gonadotrophins; Urinary FSH 150-225 IU/d; Other Names: Ovarian stimulation; Drug: GnRH antagonist; Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation; Other Names: Ovarian stimulation; Drug: GnRH agonist; GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.; Other Names: Final follicular maturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 24 hours from the oocyte collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization Rate	Percentage of properly fertilized eggs after microinjection (ICSI) method	24 hours after day of oocyte collection

Collaborators and Investigators

• Sponsor: Instituto Bernabeu
• Investigators: Principal Investigator: Juan C Castillo, Md. PhD., Instituto Bernabeu

Publications and helpful links

Helpful Links

• Setting
• Reference

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2017
• Primary Completion (Actual): January 12, 2018
• Study Completion (Actual): January 12, 2018

Study Registration Dates

• First Submitted: June 19, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): August 19, 2019
• Last Update Submitted That Met QC Criteria: July 11, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: ovarian stimulation; antagonist; random; egg donation; gnrh agonist trigger
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prolactin Release-Inhibiting Factors
• Other Study ID Numbers: IB012016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No