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

Sheba Medical Center

Status: Unknown

Conditions: Infertility

Treatments: Drug: Gonadotropins; Drug: Letrozole, Gonadotropins

Study type: Interventional

Funder types: Other

Identifiers

NCT02128360

SHEBA-14-1034-SD-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of poor responder to ovarian stimulation

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Minimal stimulation protocol

Active Comparator group

Description:

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

Treatment:

Drug: Letrozole, Gonadotropins

High dose protocol

Active Comparator group

Description:

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

Treatment:

Drug: Gonadotropins