Infertility, Female
Conditions
Brief summary
The current prospective observational pilot study aims to evaluate the endocrine profile of a single-injection protocol (single CFA + daily oral administration of CC).
Interventions
DRUGCorifollitropin alfa (CFA) 150 mcg + Clomiphene Citrate (CC) 100 mg/day from D1
On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, a single injection of 150 mcg of CFA (Stimulation Day 1) will be administered.
DRUGClomiphene Citrate (CC) 100 mg/day from D1
On day 2 or 3 of the menstrual cycle or after 5 days of pill-free interval, the patients will start oral administration of Clomiphene Citrate 100/day continuing up to and including the day of ovulation triggering
DIAGNOSTIC_TESTMonitoring cycle
Scan controls and blood exams will be performed on stimulation days 1, 6, 8, 10 and, according to clinical needs, until trigger day.
Sponsors
Fundación Santiago Dexeus Font
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Age \<= 40 AMH (Anti-Mullerian Hormone) 1.2-3.5 ng/ml or AFC 7-20 No family history of hereditary or chromosomal diseases Body mass index (BMI) 18 to 30 kg/m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Follicle stimulating hormone (FSH) | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval | FSH levels |
| Luteinizing hormone (LH) | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval | LH levels |
| Estradiol | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval | Estradiol levels |
| Progesterone | days 1, 6, 8, 10,the day of ovulation triggering, the day of ovulation triggering day+1 and 7 days after oocyte retrieval | Progesterone levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of MII oocytes | 7 -20 days from initiation of ovarian stimulation | — |
| Follicular Output Rate (FORT) | 7 -20 days from initiation of ovarian stimulation | expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation |
| Follicle-to-oocyte index (FOI) | 7 -20 days from initiation of ovarian stimulation | expressed as the ratio between the total number of oocytes retrieved at oocyte pick-up and the number of antral follicles available at the start of stimulation |
| Cancellation rate | 7 -20 days from initiation of ovarian stimulation | — |
| Ovarian hyperstimulation syndrome (OHSS) rate | Until 15 days after punction | — |
| Days of stimulation | 7 -20 days from initiation of ovarian stimulation | — |
| Number of oocytes retrieved (COCs) | 7 -20 days from initiation of ovarian stimulation | — |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORNikolaos P Polyzos, MD, PhD
Dexeus Fertility
Outcome results
None listed