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Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients (Larganta)

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

levonorgestrel and ethynilestradiol

About this trial

This is an interventional treatment trial for Infertility focused on measuring Infertility patients requiring IVF, good prognosis

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Instituto Valenciano de Infertilidad

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

OCP+GnRH antagonist

long GnRH agonist

Arm Description

Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist

daily triptorelin starting day 21st of previous cycle

Outcomes

Primary Outcome Measures

implantation rate

Secondary Outcome Measures

Full Information

NCT ID

NCT01157754

First Posted

July 6, 2010

Last Updated

April 21, 2015

Sponsor

IVI Madrid

1. Study Identification

Unique Protocol Identification Number

NCT01157754

Brief Title

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

Acronym

Larganta

Official Title

Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IVI Madrid

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Infertility patients requiring IVF, good prognosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

OCP+GnRH antagonist

Arm Type

Experimental

Arm Description

Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist

Arm Title

long GnRH agonist

Arm Type

Active Comparator

Arm Description

daily triptorelin starting day 21st of previous cycle

Intervention Type

Drug

Intervention Name(s)

levonorgestrel and ethynilestradiol

Primary Outcome Measure Information:

Title

implantation rate

Time Frame

2 weeks after the embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Instituto Valenciano de Infertilidad

City

Madrid

ZIP/Postal Code

28035

Country

Spain

12. IPD Sharing Statement

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

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