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

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02128360
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 15
• Patients Per Site Per Month: 13.3

Study Details

Study Description

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	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Mar 1, 2015
• Anticipated Primary Completion Date: Jun 1, 2016
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical pregnancy rates [1 Year]

Secondary Outcome Measures

1. Number of High quality embryos [1 year]

   How many embryos of 6-8 cells with low fragmentation in each arm

2. Number of eggs retrieved [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 43 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis of poor responder to ovarian stimulation

Exclusion Criteria:

• Patients undergoing pregestational diagnosis (PGD)

• Patients using donor eggs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Chaim Sheba Medical Center	Tel Hashomer		Israel	52621

Sponsors and Collaborators

• Sheba Medical Center

Investigators

• Principal Investigator: Shir Dar, MD, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT02128360
• Other Study ID Numbers: SHEBA-14-1034-SD-CTIL
• First Posted: May 1, 2014
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Sheba Medical Center: Low ovarian reserve; Poor responder; Infertility
• Additional relevant MeSH terms: Infertility; Letrozole

Study Results

No Results Posted as of Nov 20, 2014