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Frozen-thawed Embryo Transfer in a Naturally Stimulated Cycle: Does hCG Triggering Bring Any Advantage in Comparison to Testing LH Surge With Home Tests?

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: NCT03115320
Recruitment Status : Terminated (High cancellation rate in LH test group in interim analysis)
First Posted : April 14, 2017
Last Update Posted : June 4, 2020
Information provided by (Responsible Party):
Tampere University Hospital

Brief Summary:
The primary aim of this study is to find out if ovulation triggered with hCG provides any additional benefit in comparison to spontaneous LH surge measured with the home test when transferring frozen-thawed embryo in a naturally stimulated cycle.

Condition or disease Intervention/treatment Phase
Infertility Drug: Human chorionic gonadotropin Other: Home ovulation test Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Protocol for a Randomized, Two-Parallel-group Study to Compare the Efficacy of Testing LH Surge at Home Versus Medically Triggered Ovulation With hCG (Pregnyl®) in the Naturally Stimulated Cycle in the Frozen-thawed Embryo Transfer
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pregnyl (Human chorionic gonadotropin)
In this group, patients have natural cycle in frozen-thawed embryo transfer and the ovulation is confirmed by administration of hCG (Pregnyl® 5000 IU). The day of transferring embryo is depending on the day of administration of hCG and the age of the embryo. The day zero day is defined by ovulation triggered by hCG.
Drug: Human chorionic gonadotropin
Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.
Other Name: Home ovulation test

Home ovulation test
The patients randomized to the LH surge group perform the ovulation home test daily from the urine. Thus, the ovulation in this group is corfimed by the urine test. The day of transferring embryo is depending on the positive ovulation test and the age of the embryo. The day zero day is defined by positive ovulation test.
Other: Home ovulation test
The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.

Primary Outcome Measures :
  1. Live birth rate [ Time Frame: At possible delivery (about 40 weeks) ]

Secondary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: After two weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • - Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
  • Regular menstruation cycle
  • Patient's willingness to participate in the study

Exclusion Criteria:

  • - Irregular menstrual cycle demanding preparing endometrium with hormones for frozen-thawed embryo
  • No frozen embryos after IVF cycle
  • Allergy to Pregnyl® or some of its ingredients in the medication or other contraindications due to Pregnyl®

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): NCT03115320

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Tampere University Hospital
Tampere, Finland
Sponsors and Collaborators
Tampere University Hospital
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Principal Investigator: Helena Tinkanen Tampere University Hospital
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Responsible Party: Tampere University Hospital Identifier: NCT03115320    
Other Study ID Numbers: R16172M
2016-003959-29 ( EudraCT Number )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs