Effects of Embryogen in RIF Patients

Infertility Clinical Trial

— RIF  

Official title:

Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250768
• Other study ID #: CGRH-Embryogen
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2014
• Last updated: September 23, 2014
• Start date: July 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Vietnam National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Vietnam National University
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)

Description:

60 patients with repeated implantation failure were involved.

RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.

Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at fixed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.

Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Normal ovarian reserve (AMH > 1.1 ng/ml)

• Regular menstrual cycle (25 - 34 days)

• Clear informations about at least 3 latest IVF/ET

• Fresh embryo transfer in this cycle

• Endometrial thickness of 10 mm or more

Exclusion Criteria:

• Undergo oocyte donation or in vitro maturation (IVM) cycles

• Using frozen or surgically retrieved sperm

• Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges

• In participation in other studies/interventions

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Biological:
• GM-CSF
2ng/ml of GM-CSF supplemented into culture media

Locations

Country	Name	City	State
Vietnam	An Sinh Hospital	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Vietnam National University

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rate		12 week of gestation	No
Secondary	Implantation rate		7 week of gestation	No
Secondary	clinical pregnancy rate		7 week of gestation	No
Secondary	top quality embryo rate		44 hours after insemination	No