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

Study Overview
=================
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.

Official Title
-----------------
Random-start Ovarian Stimulation in Egg-donors (ROSE) Trial: a Self-controlled Study

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Random start ovarian stimulation
* Drug: Gonadotrophins
* Drug: GnRH antagonist
* Drug: GnRH agonist


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Random start ovarian stimulation<br>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<br>* Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.<br>* Other names: Ovarian stimulation;Drug: Gonadotrophins<br>* Urinary FSH 150-225 IU/d<br>* Other names: Ovarian stimulation;Drug: GnRH antagonist<br>* Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation<br>* Other names: Ovarian stimulation;Drug: GnRH agonist<br>* GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian stimulation, random, antagonist, gnrh agonist trigger, egg donation