Female infertility MedDRA version: 14.1 Level: LLT Classification code 10016398 Term: Female infertility System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: OMIFIN comprimidos
Pharmaceutical Form: Tablet
INN or Proposed INN: CLOMIFENO CITRATO
CAS Number: 50-41-9
Other descriptive name: CLOMIFENE CITRATE
Concentration unit: mg milligram(s)
Conc
Sponsors
Fundació Privada EUGIN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Oocyte donors - Age between 18 and 35 years. - BMI between 18 and 29 kg/m2 - Presence of both ovaries - Caucasian phenotype - Basal level of E2 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Polycystic ovarian syndrome - Previous participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of the 5-day CC administration during luteal phase on serum LH levels in oocyte donors.;Secondary Objective: To evaluate the impact of the CC administration on the development of the endometrium.;Primary end point(s): - Serum LH levels measured in the luteal phase;Timepoint(s) of evaluation of this end point: - 1st: Basal levels. (FSH, E2, and P4 required for inclusion). - 2nd: On the ovulation triggering day. - 3rd: On day 1 after OPU. - 4th: On day 5 after OPU. - 5th: On day 7 after OPU. - 6th: On day 10 after OPU. - 7th: On the first day of next period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Endometrial development on day 5 after Oocyte Pick-Up (OPU) studied by histological dating criteria of Noyes;Timepoint(s) of evaluation of this end point: - day 5 after OPU | — |
Countries
Spain
Contacts
Public ContactClinical Research Information
Fundació Privada EUGIN
Outcome results
None listed