Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles

Female Infertility Clinical Trial

— CLOFA  

Official title:

Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.

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

• Female Infertility
• Infertility, Female

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