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Trial record 31 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

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ClinicalTrials.gov Identifier: NCT03115320
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : May 16, 2019
Sponsor:
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)
Estimated Enrollment : 330 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
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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 ]


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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • - Patient with IVF 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 ClinicalTrials.gov identifier (NCT number): NCT03115320


Contacts
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Contact: Helena Tinkanen helena.tinkanen@pshp.fi
Contact: Riikka Leppänen riikka.leppanen@pshp.fi

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Helena Tinkanen, M.D., Ph.D.       helena.tinkanen@pshp.fi   
Contact: Riikka Leppänen, M.D.       riikka.leppanen@pshp.fi   
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Principal Investigator: Helena Tinkanen Tampere University Hospital

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03115320     History of Changes
Other Study ID Numbers: R16172M
2016-003959-29 ( EudraCT Number )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: April 2019

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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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Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs