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Completed

NCT Number: NCT02250768

Effects of Embryogen in RIF Patients

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)

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

An Sinh Hospital, Ho Chi Minh City, Ho Chi Minh, Vietnam

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GM-CSF

Biological

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

Primary outcomes

  1. ongoing pregnancy rate

    Time frame: 12 week of gestation

Secondary outcomes

  1. Implantation rate

    Time frame: 7 week of gestation

  2. clinical pregnancy rate

    Time frame: 7 week of gestation

  3. top quality embryo rate

    Time frame: 44 hours after insemination

Sponsors and collaborators

Lead sponsor

Vietnam National University

Other

Registry information

Official study title

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

Acronym: RIF

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 26, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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