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Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02825290
Recruitment Status : Unknown
Verified December 2016 by Dr. Eran Zilberberg, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : July 7, 2016
Last Update Posted : December 13, 2016
Information provided by (Responsible Party):
Dr. Eran Zilberberg, Sheba Medical Center

Brief Summary:
This study evaluates the outcomes of frozen-thawed embryo transfer (FET) success rate with modified luteal support - addition of a single injection of HCG and GnRH-agonist, on day of ET and 4 days later, respectively vs. traditional luteal support with vaginal progesterone only in ovulating women.

Condition or disease Intervention/treatment Phase
Embryo Transfer Luteal Support Drug: Choriogonadotropin alfa Drug: Triptorelin acetate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Modified Luteal Support for Frozen-Thawed Embryo Transfer - A Prospective Study
Study Start Date : July 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Study group
hCG (Choriogonadotropin alfa; Ovitrelle 250 mcg) on day of embryo transfer & GnRH-agonist (Triptorelin acetate; Decapeptyl 0.1 mg) after 4 days In addition to the usual progesterone luteal support.
Drug: Choriogonadotropin alfa
Other Names:
  • recombinant hCG
  • Ovitrelle
  • Ovidrel

Drug: Triptorelin acetate
Other Names:
  • GnRH-Agonist
  • Decapeptyl

No Intervention: Control group
The usual progesterone only luteal phase support.

Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: About 10-12 weeks after embryo transfer ]
    Number of viable pregnancies at about 10-12 weeks of gestation.

Secondary Outcome Measures :
  1. Implantation rate [ Time Frame: 2 weeks after embryo transfer ]
    Positive BhCG blood test

  2. Clinical pregnancy [ Time Frame: About 3-4 weeks after embryo transfer ]
    Visible intrauterine gestational sacs on ultrasound exam

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 20-40 years old women
  • Spontaneously ovulating women
  • Treated in our IVF unit for frozen-thawed embryo transfer
  • At least one top quality embryo

Exclusion Criteria:

  • PGD patients
  • More than 4 previous embryo transfers

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 identifier (NCT number): NCT02825290

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Contact: Eran Zilberberg, MD +97235302882
Contact: Raoul Orvieto, MD +97235302882

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Sheba medical center Recruiting
Ramat Gan, Israel
Contact: Eran Zilberberg, MD    +97235302882      
Sponsors and Collaborators
Sheba Medical Center
Orvieto R, Fisch B, Feldberg D. Endometrial Preparation for Patients undergoing Frozen- Thawed Embryo Transfer Cycles. In: The Art & Science of Assisted Reproductive Techniques. G. Allahbadia, R. asuray, R. Merchant, Eds. Jaypee Brothers Medical Publishers (P) Ltd. New Delhi, India, 2003, pp. 396-9.

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Responsible Party: Dr. Eran Zilberberg, Doctor, Sheba Medical Center Identifier: NCT02825290    
Other Study ID Numbers: 2537-15-SMC
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: December 13, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Eran Zilberberg, Sheba Medical Center:
Frozen-thawed embryo transfer (FET)
Luteal support
Natural cycle
Pregnancy rate
Additional relevant MeSH terms:
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Triptorelin Pamoate
Chorionic Gonadotropin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents