A Comparative Study of Two Patterns of Controlled Ovarian Hyperstimulation in Mid Follicular Phase or Early Luteal Phase for Egg Donors

NCT ID: NCT01385332

Last Updated: 2017-09-20

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to determine the efficacy and safety of two new patterns of controlled ovarian hyperstimulation (defined as total number of picked up eggs). This study will be performed in egg donors but these new patterns will be implemented in fertility preservation patients.

Detailed Description

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Conditions

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Stimulation in the Ovary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early luteal phase -COH-

We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the early luteal phase.

Group Type ACTIVE_COMPARATOR

Early luteal phase

Intervention Type PROCEDURE

We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.

Late folicular phase - COH -

We perform an standard antagonist protocol beginning the second day of the menstrual cycle compared with an antagonist protocol beginning in the late follicular phase.

Group Type ACTIVE_COMPARATOR

Late follicular phase -COH-

Intervention Type PROCEDURE

We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.

Interventions

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Early luteal phase

We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.

Intervention Type PROCEDURE

Late follicular phase -COH-

We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* premenopausal women 18-30 years old, with FSH levels \< 10mIU
* irregular menstrual cycle
* BMI between 12-28
* signed inform consent

Exclusion Criteria

* Polycystic ovarian syndrome, gonadotropins allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Miguel Angel Checa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Servei de Ginecologia i Obstetricia, Hospital del Mar-Parc Salut Mar

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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UREP-ONCO-2010

Identifier Type: -

Identifier Source: org_study_id