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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
mild ovarian stimulation
conventional ovarian stimulation
Sponsored by
National and Kapodistrian University of Athens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • 3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mild ovarian stimulation

conventional ovarian stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

number of oocytes (COCs)

Secondary Outcome Measures

Number/rate of participants whom the IVF cycle was cancelled
clinical pregnancy rate
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention
live birth
miscarriage
stimulation characteristics
total dose of gonadotropins administered,
cancellation rate
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

Full Information

First Posted
March 8, 2011
Last Updated
November 7, 2015
Sponsor
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01319708
Brief Title
Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Official Title
Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National and Kapodistrian University of Athens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mild ovarian stimulation
Arm Type
Experimental
Arm Description
100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering
Arm Title
conventional ovarian stimulation
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
mild ovarian stimulation
Intervention Description
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
Intervention Name(s)
conventional ovarian stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
number of oocytes (COCs)
Time Frame
at oocyte recovery
Secondary Outcome Measure Information:
Title
Number/rate of participants whom the IVF cycle was cancelled
Time Frame
After the 1st week of ovarian stimulation, no oocytes at OR
Title
clinical pregnancy rate
Description
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention
Time Frame
6 weeks
Title
live birth
Time Frame
more than 20 weeks
Title
miscarriage
Time Frame
pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
Title
stimulation characteristics
Description
total dose of gonadotropins administered,
Time Frame
from start of stimulation until embryo transfer
Title
cancellation rate
Description
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
Time Frame
from start of stimulation until ET

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit
City
Athens
State/Province
Chaidari
ZIP/Postal Code
12462
Country
Greece

12. IPD Sharing Statement

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

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