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

NCT ID: NCT01157754

Last Updated: 2015-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCP+GnRH antagonist

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

Group Type EXPERIMENTAL

levonorgestrel and ethynilestradiol

Intervention Type DRUG

long GnRH agonist

daily triptorelin starting day 21st of previous cycle

Group Type ACTIVE_COMPARATOR

levonorgestrel and ethynilestradiol

Intervention Type DRUG

Interventions

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levonorgestrel and ethynilestradiol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Instituto Valenciano de Infertilidad

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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MAD-GV-05-2009-01

Identifier Type: -

Identifier Source: org_study_id

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