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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02128360
Enrollment
200
Registered
2014-05-01
Start date
2015-03-31
Completion date
2016-06-30
Last updated
2014-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Low ovarian reserve, Poor responder, Infertility

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.

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.

Interventions

DRUGLetrozole, Gonadotropins

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
No

Inclusion criteria

* Clinical diagnosis of poor responder to ovarian stimulation

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rates1 Year

Secondary

MeasureTime frameDescription
Number of High quality embryos1 yearHow many embryos of 6-8 cells with low fragmentation in each arm
Number of eggs retrieved1 year

Countries

Israel

Contacts

Primary ContactShir Dar, MD
dr.shirdar@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026