OTHER
Random start ovarian stimulation
Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
Random-start Ovarian Stimulation in Egg-donors (ROSE)
Status
Terminated
Phase
Phase 4
Enrollment
15
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Gonadotrophins
Urinary FSH 150-225 IU/d
DRUG
GnRH antagonist
Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
DRUG
GnRH agonist
GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
Timeline
From registration to results.
First posted
Jul 4, 2016
Study start
Jan 10, 2017
Primary completion
Jan 12, 2018
Study completion
Jan 12, 2018
Results posted
Aug 19, 2019
Registry updated
Aug 19, 2019
Outcomes
What the study measures.
Primary outcomes
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.
Secondary outcomes
Fertilization Rate
Time frame · 24 hours after day of oocyte collection
Percentage of properly fertilized eggs after microinjection (ICSI) method
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 35 Years
- Sex
- FEMALE
- Healthy volunteers
- Yes
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 locations
1 registered sites.
Spain. Showing up to 24 locations stored in the fast local snapshot.
Instituto Bernabeu
Alicante, Spain
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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