Effects of Embryogen in RIF Patients

• Sponsor: Vietnam National University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02250768
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Infertility	Biological: GM-CSF	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GM-CSF Injected oocytes were cultured in GM-CSF supplemented media until day of transfer	Biological: GM-CSF; 2ng/ml of GM-CSF supplemented into culture media

Outcome Measures

Primary Outcome Measures

1. ongoing pregnancy rate [12 week of gestation]

Secondary Outcome Measures

1. Implantation rate [7 week of gestation]

2. clinical pregnancy rate [7 week of gestation]

3. top quality embryo rate [44 hours after insemination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	An Sinh Hospital	Ho Chi Minh		Vietnam

Sponsors and Collaborators

• Vietnam National University

Investigators

• Principal Investigator: Vinh Q Dang, Dr, Research Center for Genetics and Reproductive Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dang Quang Vinh, Dr, Vietnam National University
• ClinicalTrials.gov Identifier: NCT02250768
• Other Study ID Numbers: CGRH-Embryogen
• First Posted: Sep 26, 2014
• Last Update Posted: Sep 26, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Dang Quang Vinh, Dr, Vietnam National University: GM-CSF, repeated implantation failure
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Sep 26, 2014