Gcsf Injection in Women With Repeated Implantaiton Failure

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to see the impact of intrauterine injection of recombinant GCSF on pregnancy and implantation rate during IVF-ICSI (intracytoplasmic sperm injection) protocols as well as in frozen embryo transfer. In addition, following the injection, the level of G-CSF in the bloodstream will be verified.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Ovo; OVO R & D
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

• Women between the ages of 18 and 37

• Indication of the Antagonist IVF protocol or indication of a substituted frozen embryo transfer

• Subjects with repetitive embryo implantation failure meaning: a history of 3 embryos transferred including frozen embryo without a positive pregnancy test for women 35 years and younger

• Subjects with repetitive embryo implantation failure meaning: a history of 4 embryos transferred including frozen embryo without a positive pregnancy test for women between the ages of 35 and 37.

• Negative repetitive implantation failure work up

Exclusion Criteria:

• Renal failure or cardiac failure

• Chronic neutropenia

• Past or present cancer history

• Sickle cell anemia

• Lithium treatment

• Voluntary withdrawal from the study

• Use of concomitant medication: DHEA (dehydroepiandrosterone ), CoQ10 (coenzyme Q10), Growth Hormone and Viagra