Infertility
Conditions
Brief summary
To evaluate the effect of random-start of ovarian stimulation initiated in the early follicular or luteal phase on the pharmacokinetics and follicular dynamics and embryo euploidy rates in oocyte donors treated with identical ovarian stimulation protocols with corifollitropin alfa and GnRH antagonist pituitary downregulation
Detailed description
The scope of the current prospective trial is to investigate whether Luteal Stimulation (LS) results in equivalent euploid embryos with Follicular Stimulation (FS) in young reproductive age women. The use of the oocyte donor model allows extrapolation of the results and application of LS routinely not only in healthy women undergoing fertility preservation but also in all patients irrespective of the menstrual date. This may indeed allow widespread introduction of LS in IVF programs which may result in proper scheduling of ovarian stimulation which is a major issue in everyday clinical practice. Given that the pharmacokinetics and follicular dynamics of 150μg corifollitropin alfa for luteal stimulation has never been evaluated, the current study of luteal stimulation with corifollitropin alfa could be very interesting for several reasons: 1. Potentially immediate synchronization of oocyte donors with recipients aiming to fresh oocyte donation. 2. Fertility preservation patients for medical, oncological and non-medical indication 3. Any situation in which endometrial receptivity is not pursued.
Interventions
DRUGFollicular phase corifollitropin alfa
GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
DRUGLuteal phase corifollitropin alfa
GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)
Sponsors
Fundacion Dexeus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Overall, 44 oocyte donors women will be asked to participate in a trial in which they will undergo 2 consecutive ovarian stimulation protocols within a period of 6 months with 150μg corifollitropin alfa followed by 200 IU rFSH in a fixed GnRH antagonist protocol starting in the early follicular, and luteal menstrual cycle phase
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy eligible oocyte donors 2. Age 18-34 years 3. AFC \>12 and AMH\>1.5 ng/ml 4. BMI 19-28kg/m2 5. Body weight \>60kg 6. Both ovaries present 7. Willing to participate in the study 8. Willing to use non-hormonal contraception or not needing contraception Recipients will be eligible only if their partners' sperm which will be used for ICSI will be normal. Couples will be excluded in case of moderate to severe oligoasthenospermia.
Exclusion criteria
1. Endometriosis 2. AFC\>20 3. PCOS 4. Low ovarian reserve 5. Endocrine abnormalities 6. Hormonal contraception 7. Contraindication of hormonal treatment 8. History of Ovarian Hyperstimulation Syndrome or hyper-response (\> 30 follicles . 11mm)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean number of euploid embryos | 15-45 days following oocyte retrieval procedure | Number of euploid embryos between oocytes received from follicular phase or luteal phase initiation of ovarian stimulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of oocytes | 9 -20 days from initiation of ovarian stimulation | The outcome will be evaluated on the day of oocyte retrieval |
| Number of MIIs | 9 -20 days from initiation of ovarian stimulation | The outcome will be evaluated on the day of oocyte retrieval |
| Total additional dose of rFSH (IU) | 9 -20 days from initiation of ovarian stimulation | Addition total units of FSH following corifollitropin alfa.The outcome will be evaluated on the day of final oocyte maturation |
| Duration of ovarian stimulation | 9 -20 days from initiation of ovarian stimulation | Total days of ovarian stimulation .The outcome will be evaluated on the day of final oocyte maturation |
| Endocrine profile at specific intervals | Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15) | Estradiol, LH, FSH, Progesterone |
| Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation | 5-8 weeks after embryo transfer procedure | Clinical pregnancy rates , presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity |
Countries
Spain
Outcome results
None listed