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

NCT02821819 | Terminated Phase 4 Results

• 1 other identifier: IB012016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

ovarian stimulation; random; egg donation; antagonist; gnrh agonist trigger

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fertilization Rate

  24 hours after day of oocyte collection

Study Arms (1)

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

Other: Random start ovarian stimulation; Drug: Gonadotrophins; Drug: GnRH antagonist; Drug: GnRH agonist

Interventions

Random start ovarian stimulation OTHER

Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.

Also known as: Ovarian stimulation

Random start ovarian stimulation

Gonadotrophins DRUG

Urinary FSH 150-225 IU/d

Also known as: Ovarian stimulation

Random start ovarian stimulation

GnRH antagonist DRUG

Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation

Also known as: Ovarian stimulation

Random start ovarian stimulation

GnRH agonist DRUG

GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.

Also known as: Final follicular maturation

Random start ovarian stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women
• years old
• FSH levels \< 10 IU/liter
• Antral follicle count (AFC) \> 10
• Regular cycles
• Body Mass Index (BMI) \< 28
• Signed informed consent

You may not qualify if:

• Polycystic ovary syndrome (PCOS) patients
• Allergy to gonadotrophins
• Concomitant participation in other trial

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Related Links

• Setting
• Reference

MeSH Terms

Conditions

Infertility

Interventions

Ovulation Induction; Gonadotropins; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Limitations and Caveats

Early termination. Only random-start follicular phase stimulation was completed. 01 patient was withdrawn from analysis due to protocol violation: error in administration of medication

Results Point of Contact

• Title: Dr. Juan Carlos Castillo
• Organization: Instituto Bernabeu

jcastillo@institutobernabeu.com

+34650562634

Study Officials

• Juan C Castillo, Md. PhD.

  Instituto Bernabeu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Md. PHd.

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 4, 2016
• Study Start: January 10, 2017
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)