Impact of Clomiphene Citrate Administration During the Ea... | NCT01791751

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

NCT01791751

Sponsor

Fundació Privada Eugin

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Female Infertility

Interventions

Clomifene Citrate

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-002173-33	EudraCT Number

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Feb 2013Actual

Completion Date

Feb 2013Actual

First Submitted Date

Nov 12, 2012

First Submission Date that Met QC Criteria

Feb 12, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clomifene Citrate	Experimental	Clomifene Citrate 50 mg	Drug: Clomifene Citrate
Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomifene Citrate	Drug	Clomiphene citrate 100 mg daily for 5 days	Clomifene Citrate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LH Levels (IU)		Luteal phase (up to 2 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Endometrial development (Noyes criteria)		Luteal phase (1 day)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marta Colodron, MD	Clinica EUGIN	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clínica EUGIN		Barcelona	Barcelona	08029	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007247	Infertility, Female

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided