Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation

NCT ID: NCT01319708

Last Updated: 2015-11-10

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

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-09-30

Brief Summary

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The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.

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

SINGLE

Participants

Study Groups

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mild ovarian stimulation

100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering

Group Type EXPERIMENTAL

mild ovarian stimulation

Intervention Type PROCEDURE

100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery

conventional ovarian stimulation

300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol

Group Type ACTIVE_COMPARATOR

conventional ovarian stimulation

Intervention Type PROCEDURE

300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol

Interventions

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mild ovarian stimulation

100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery

Intervention Type PROCEDURE

conventional ovarian stimulation

300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* poor responders (age\>40, previous POR, abnormal OR test)
* indication for IVF
* regular cycling patients
* BMI 19-35

Exclusion Criteria

* contraindication for clomiphene citrate use or to GnRH agonists antagonists
* BMI \> 35
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Siristatidis Charalampos, MD, PhD

Assistant Professor, Director of the ARU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit

Athens, Chaidari, Greece

Site Status

Countries

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Greece

Other Identifiers

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1234561

Identifier Type: -

Identifier Source: org_study_id

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