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

November 7, 2015 updated by: Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Chaidari
      • Athens, Chaidari, Greece, 12462
        • 3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mild ovarian stimulation
100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering
Procedure: 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
Active Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of oocytes (COCs)
Time Frame: at oocyte recovery
at oocyte recovery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number/rate of participants whom the IVF cycle was cancelled
Time Frame: After the 1st week of ovarian stimulation, no oocytes at OR
After the 1st week of ovarian stimulation, no oocytes at OR
clinical pregnancy rate
Time Frame: 6 weeks
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention
6 weeks
live birth
Time Frame: more than 20 weeks
more than 20 weeks
miscarriage
Time Frame: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
stimulation characteristics
Time Frame: from start of stimulation until embryo transfer
total dose of gonadotropins administered,
from start of stimulation until embryo transfer
cancellation rate
Time Frame: from start of stimulation until ET
when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization
from start of stimulation until ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 8, 2011

First Submitted That Met QC Criteria

March 21, 2011

First Posted (Estimate)

March 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 7, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1234561

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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