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Embryo Transfer: Embryo Expulsion and Outcome

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ClinicalTrials.gov Identifier: NCT00905788
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : April 20, 2010
Information provided by:
Royan Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Infertility Procedure: prevention of embryo expulsion Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embryo Transfer: Embryo Expulsion and Outcome
Study Start Date : February 2008
Primary Completion Date : July 2009
Study Completion Date : December 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 4-6 weeks ]

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 6-7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905788

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

Additional Information:
Responsible Party: Hamid Gourabi, Chief, Royan Institute
ClinicalTrials.gov Identifier: NCT00905788     History of Changes
Other Study ID Numbers: Royan-Emb-001
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

Keywords provided by Royan Institute:
Embryo transfer
Embryo expulsion

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