Embryo Transfer: Embryo Expulsion and Outcome

This study has been completed.
Sponsor:
Information provided by:
Royan Institute
ClinicalTrials.gov Identifier:
NCT00905788
First received: May 20, 2009
Last updated: April 17, 2010
Last verified: April 2010
  Purpose

According to the studies, about 80% of patients undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer process, but only a few of them become pregnant.

The cause of this difference can be due to some factors such as the endometrial receptivity, quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s) following embryo transfer is (are) one of the factors which may be effective on outcome. The purpose of this randomized clinical trial study is "Lowering embryo expulsion following embryo transfer to improve outcome."


Condition Intervention Phase
Infertility
Procedure: prevention of embryo expulsion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Embryo Transfer: Embryo Expulsion and Outcome

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Clinical pregnancy [ Time Frame: 4-6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 6-7 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 134
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Embryo transfer without any intervention
Experimental: Embryo Expulsion Procedure: prevention of embryo expulsion
The prevention of embryo expulsion will be carried out after embryo transfer

Detailed Description:

A total of 134 infertile women who undergo IVF or ICSI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups of 67 patients. This study has been approved by Royan ethics committee and written consent will be obtained from each patient. The patients with frozen-thawed embryo transfer cycle and those with oocyte donation cycle, the women with uterine abnormality and the subjects with submucosal and intramural myoma, will be excluded from this study.

After the ovarian stimulation and oocyte retrieval, The IVF and intracytoplasmic sperm injection (ICSI) procedures will be performed to produce the embryos.

Embryo transfer will be done only by one skilled physician. The patients will be divided into two groups of A and B by computerized randomly chart. In group A, the prevention technique of embryo expulsion will be carried out following embryo transfer, but no intervention will be performed in group B (control group).

After 2 weeks, the patients will be tested for serum β-hCG for assessing the pregnancy. The clinical pregnancy will be clarified by the number of women with gestational sacs on transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the number of gestational sacs will be considered.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women undergoing IVF or ICSI treatment cycle
  • Patients with "long or antagonist" protocol

Exclusion Criteria:

  • The patients with frozen-thawed embryo transfer cycle
  • Those with oocyte donation cycle
  • The women with uterine abnormality
  • The women with submucosal and intramural myoma
  • Who does not have good-quality embryos appropriate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905788

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Principal Investigator: Tahere Madani, MD Royan Institute
Principal Investigator: Mahnaz Ashrafi, MD Royan Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT00905788     History of Changes
Other Study ID Numbers: Royan-Emb-001
Study First Received: May 20, 2009
Last Updated: April 17, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Royan Institute:
Embryo transfer
IVF/ICSI
Embryo expulsion

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 22, 2014