Oral Contraceptive Pill and GnRH Antagonist Versus Long P... | NCT01157754

Studies
Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients

NCT01157754

Sponsor

IVI Madrid

Status

Completed

Last Update Posted

Apr 22, 2015Estimated

Enrollment

115Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

levonorgestrel and ethynilestradiol

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

Status Module

Record Verification Date

Apr 2015

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 2009

Primary Completion Date

May 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

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

Apr 21, 2015

Last Update Posted Date

Apr 22, 2015Estimated

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

Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCP+GnRH antagonist	Experimental	Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist	Drug: levonorgestrel and ethynilestradiol
long GnRH agonist	Active Comparator	daily triptorelin starting day 21st of previous cycle	Drug: levonorgestrel and ethynilestradiol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levonorgestrel and ethynilestradiol	Drug		OCP+GnRH antagonist long GnRH agonist

Measure	Description	Time Frame
implantation rate		2 weeks after the embryo transfer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1st or 2nd IVF cycle
BMI <30 kg/m2
regular menstrual cycles
basal FSH <10 IU and E2 <60 pg/ml

Exclusion Criteria:

Polycystic ovaries
endometriosis
previous ovarian surgery
previous low ovarian response

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

38 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Instituto Valenciano de Infertilidad		Madrid	Madrid	28035	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016912	Levonorgestrel

Ancestor Terms

ID	Term
D009644	Norgestrel
D009652	Norpregnenes
D009650	Norpregnanes
D009654	Norsteroids
D013256

Browse Leaves

Not provided

Browse Branches

Not provided