Clinical trial NCT03555942: Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa
Official title: Follicular or Luteal Start Ovarian Stimulation With Corifollitropin Alfa. A Prospective Equivalence Study With Repeated Ovarian Stimulation in Oocyte Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Fundacion Dexeus
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Mean number of euploid embryos
timeFrame: 15-45 days following oocyte retrieval procedure
Secondary outcomes:
measure: Number of oocytes
timeFrame: 9 -20 days from initiation of ovarian stimulation
measure: Number of MIIs
timeFrame: 9 -20 days from initiation of ovarian stimulation
measure: Total additional dose of rFSH (IU)
timeFrame: 9 -20 days from initiation of ovarian stimulation
measure: Duration of ovarian stimulation
timeFrame: 9 -20 days from initiation of ovarian stimulation
measure: Endocrine profile at specific intervals
timeFrame: Stimulation day 1, day 6, day 8, and Day of final oocyte maturation (actual day may vary between 9-15)
measure: Clinical pregnancy rates following transfer of embryos generated from oocytes from follicular phase vs. luteal phase stimulation
timeFrame: 5-8 weeks after embryo transfer procedure
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Consultorio Dexeus
city: Barcelona
country: Spain
facility: Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus
Study officials:
References:
citation: Martinez F, Clua E, Roca M, Garcia S, Polyzos NP. Comparison of blastocyst euploidy rates following luteal versus follicular phase stimulation in a GnRH antagonist protocol: a prospective study with repeated ovarian stimulation cycles. Hum Reprod. 2022 Nov 24;37(12):2777-2786. doi: 10.1093/humrep/deac222.