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OpenTrials
Completed

NCT Number: NCT02158689

Comparison of Treatment Modalities in Poor Responders Undergoing IVF

The accurate identification and efficient management of poor responders remains one of the most enigmatic challenges in assisted reproductive technology (ART). The investigators study will compare the letrozole/antagonist protocol to the hMG/antagonist protocol in women who poor responders.

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Key information

Conditions

Poor Responders

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients will be considered eligible if they are poor ovarian responders according to the Bologna criteria (Ferraretti et al., 2011).
  • Two out of three of the following criteria are essential in order to classify a patient as poor ovarian responder:
  • advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
  • a poor ovarian response (≤3 oocytes with a conventional stimulation protocol); or
  • an abnormal ovarian reserve test (antral follicle count, <7 follicles or anti-Mullerian hormone, <1.1 ng/ml).

Treatment and study plan

letrozole

Drug

Other names: Femara

human menopausal gonadotropin (hMG)

Drug

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: up to 2 weeks

    The primary outcome measure will be the ongoing pregnancy rate (>12 weeks' gestation) per started cycle.

Secondary outcomes

  1. Cancellation Rate

    Time frame: up to one month

    One of the secondary outcome measures will be cancellation rate.

  2. Number of oocytes retrieved

    Time frame: up to one month

    One of the secondary outcome measures will be number of oocytes retrieved.

  3. Number of transferable embryos

    Time frame: up to one month

    One of the secondary outcome measures will be number of transferable embryos.

  4. Implantation rate

    Time frame: up to 2 weeks

    One of the secondary outcome measures will be implantation rates.

  5. Clinical pregnancy rate

    Time frame: up to 2 weeks

    One of the secondary outcome measures will be clinical pregnancy rates.

Sponsors and collaborators

Lead sponsor

Ercan Bastu

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 9, 2014
Registry last updated
Jan 8, 2016

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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