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Comparison of 2 Ovarian Stimulation Protocols for Women With Low Ovarian Reserve

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ClinicalTrials.gov Identifier: NCT02128360
Recruitment Status : Unknown
Verified November 2014 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2014
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:
The purpose of this study is to determine whether minimal ovarian stimulation for in vitro fertilization is superior to high dose stimulation. Number of mature eggs, number of embryos as well as pregnancy rates will be compared.

Condition or disease Intervention/treatment Phase
Infertility Drug: Letrozole, Gonadotropins Drug: Gonadotropins Not Applicable

Detailed Description:
A prospective randomized trial will be carried out. The Minimal stimulation (MS) protocol is based on low dose letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the letrozole at 150 units per day. GnRH antagonist wil be introduced to avoid premature LH surge when one or more of the growing follicles reached approximately 14 mm in size. The high dose stimulation protocol is based on high dose of gonadotropins (≥300 IU/day) throughout the cycle with the usage of gonadotropin-releasing hormone (GnRH) antagonist to avoid premature luteinizing hormone (LH) surge as described above.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve
Study Start Date : March 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Letrozole

Arm Intervention/treatment
Active Comparator: Minimal stimulation protocol
Low dose Letrozole 2.5 mg over 5 days, starting from cycle day 2, overlapping with low dose gonadotropins, starting from day 3 of the Letrozole at 150 units per day. GnRH antagonist to avoid premature LH surge will be introduced when one or more of the growing follicles reached approximately 14 mm in size
Drug: Letrozole, Gonadotropins
Active Comparator: High dose protocol
High dose of gonadotropins (≥300 IU/day) starting from cycle day 3. GnRH antagonist will be introduced to avoid premature LH surge when one or more of the growing follicles will reach approximately 14 mm in size
Drug: Gonadotropins



Primary Outcome Measures :
  1. Clinical pregnancy rates [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. Number of High quality embryos [ Time Frame: 1 year ]
    How many embryos of 6-8 cells with low fragmentation in each arm

  2. Number of eggs retrieved [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria:

  • Patients undergoing pregestational diagnosis (PGD)
  • Patients using donor eggs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128360


Contacts
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Contact: Shir Dar, MD dr.shirdar@gmail.com

Locations
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Israel
The Chaim Sheba Medical Center Not yet recruiting
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Shir Dar, MD Sheba Medical Center

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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02128360     History of Changes
Other Study ID Numbers: SHEBA-14-1034-SD-CTIL
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Sheba Medical Center:
Low ovarian reserve
Poor responder
Infertility

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs