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NCT Number: NCT01319708

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit

Athens, Chaidari, 12462, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mild ovarian stimulation

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

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

Primary outcomes

  1. number of oocytes (COCs)

    Time frame: at oocyte recovery

Secondary outcomes

  1. Number/rate of participants whom the IVF cycle was cancelled

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

  2. 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

  3. live birth

    Time frame: more than 20 weeks

  4. miscarriage

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

  5. stimulation characteristics

    Time frame: from start of stimulation until embryo transfer

    total dose of gonadotropins administered,

  6. 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

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2011
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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