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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01791751
Other study ID # CLOFA
Secondary ID 2011-002173-33
Status Completed
Phase Phase 4
First received November 12, 2012
Last updated February 12, 2013
Start date June 2012
Est. completion date February 2013

Study information

Verified date February 2013
Source Fundació Privada Eugin
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Agency of Medicines
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Oocyte donors

- 18-35 years old

- BMI 18-29 Kg/m2

- Normal basal hormonal levels

- No contraceptive pill

Exclusion Criteria:

- Polycystic ovarian syndrome (PCOS)

- Previous participation in the study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Drug:
Clomifene Citrate
Clomiphene citrate 100 mg daily for 5 days

Locations

Country Name City State
Spain Clínica EUGIN Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Privada Eugin

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary LH Levels (IU) Luteal phase (up to 2 weeks) No
Secondary Endometrial development (Noyes criteria) Luteal phase (1 day) No
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