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

Infertility Clinical Trial

Official title:

Analysis of IVF Outcome After Minimal Stimulation vs. High Dose Stimulation for Patients With Low Ovarian Reserve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02128360
• Other study ID #: SHEBA-14-1034-SD-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 23, 2014
• Last updated: November 19, 2014
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2014
• Source: Sheba Medical Center
• Contact: Shir Dar, MD
• Email: dr.shirdar[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria:

• Patients undergoing pregestational diagnosis (PGD)

• Patients using donor eggs

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Letrozole, Gonadotropins

• Gonadotropins

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rates		1 Year	No
Secondary	Number of High quality embryos	How many embryos of 6-8 cells with low fragmentation in each arm	1 year	No
Secondary	Number of eggs retrieved		1 year	No