Status:
UNKNOWN
N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
Lead Sponsor:
Angelini Farmacéutica
Collaborating Sponsors:
Sistemas Genómicos
Conditions:
In Vitro Fertilization
Controlled Ovarian Stimulation
Eligibility:
FEMALE
18-37 years
Brief Summary
This project wants to determinate whether there is a relationship between the N680S polymorphism genotype of the FSHR gene and the nature of the FSH used in controlled ovarian stimulation. It is a no...
Detailed Description
The investigators want to investigate whether the N680S polymorphism of the FSRH gene could affects ovarian response with different nature of the FSH used (human FSH and recombinant FSH) in patients u...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signature of Informed Consent
- Age ≤ 37 years
- BMI \< 30 kg/m2
- Antral follicles count 1st cycle COS = 5-15
- Antimüllerian hormone basal 1st cycle COS \> 1,1 ng/ml and \< 3,1 ng/ml
- COS protocol: equal starting dose in the 2 cycles of COS (150-225 UI/day) with dose adjustment from the 5th day of COS; pituitary suppression protocol in the 2 cycles of COS with GnRH antagonist with onset when ≥ 1 follicle of ≥ 14 mm in diameter or E2 ≤ 600 pg/ml; and triggering with hCGr or GnRH agonist
- Optional the use of oral contraceptives (OC) (however, same in the 2 cycles)
- 4-9 recovered oocytes in the 1st cycle of COS
- ≤ 6 months between the 2 cycles of COS
- Exclusion criteria:
- Use of the LH activity during the cycles of COS
- Presence of severe male factor
- Grade III-IV endometriosis
- Patients with polycystic ovary syndrome, a history of uterine or ovarian surgeries, hydrosalpinx visible by ultrasound, or uterine fibroids measuring \> 30 mm
- Major systemic or uncontrolled endocrine-metabolic diseases affecting the pituitary gland, the thyroid gland, the adrenal glands, the pancreas, the liver, or the kidneys
Exclusion
Key Trial Info
Start Date :
September 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04122729
Start Date
September 25 2019
End Date
June 1 2020
Last Update
October 10 2019
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
2
Hospital Clínic
Barcelona, Spain
3
Hospital Universitario Vall d'Hebron
Barcelona, Spain
4
Hospital Universitario Reina Sofía
Córdoba, Spain