NCT01319708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

4.5 years

First QC Date

March 8, 2011

Last Update Submit

November 7, 2015

Conditions

Infertility

Keywords

ovarian stimulationclimiphene citrateGonadotropin-Releasing Hormone agonists/antagonistsFollicle Stimulating Hormone

Outcome Measures

Primary Outcomes (1)

  • number of oocytes (COCs)

    at oocyte recovery

Secondary Outcomes (6)

  • Number/rate of participants whom the IVF cycle was cancelled

    After the 1st week of ovarian stimulation, no oocytes at OR

  • clinical pregnancy rate

    6 weeks

  • live birth

    more than 20 weeks

  • miscarriage

    pregnancy loss before 20 weeks of gestation, after a positive pregnancy test

  • stimulation characteristics

    from start of stimulation until embryo transfer

  • +1 more secondary outcomes

Study Arms (2)

mild ovarian stimulation

EXPERIMENTAL

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

Procedure: mild ovarian stimulation

conventional ovarian stimulation

ACTIVE COMPARATOR

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

Interventions

mild ovarian stimulationPROCEDURE

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

mild ovarian stimulation
conventional ovarian stimulationPROCEDURE

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

conventional ovarian stimulation

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • contraindication for clomiphene citrate use or to GnRH agonists antagonists
  • BMI \> 35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit

Athens, Chaidari, 12462, Greece

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Director of the ARU

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

GR(1)