Back to resultsFrozen-thawed Embryo Transfer in a Naturally Stimulated Cycle: Does hCG Triggering Bring Any Advantage in Comparison to Testing LH Surge With Home Tests?
Primary Purpose
Infertility
Status
Terminated
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Human chorionic gonadotropin
Home ovulation test
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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®
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Pregnyl (Human chorionic gonadotropin)
Home ovulation test
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Live birth rate
Secondary Outcome Measures
Ongoing pregnancy rate
Full Information
NCT ID
NCT03115320
First Posted
November 17, 2016
Last Updated
June 1, 2020
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03115320
Brief Title
Frozen-thawed Embryo Transfer in a Naturally Stimulated Cycle: Does hCG Triggering Bring Any Advantage in Comparison to Testing LH Surge With Home Tests?
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
High cancellation rate in LH test group in interim analysis
Study Start Date
January 2017 (Actual)
Primary Completion Date
November 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pregnyl (Human chorionic gonadotropin)
Arm Type
Experimental
Arm Description
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.
Arm Title
Home ovulation test
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Human chorionic gonadotropin
Other Intervention Name(s)
Home ovulation test
Intervention Description
Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.
Intervention Type
Other
Intervention Name(s)
Home ovulation test
Intervention Description
The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.
Primary Outcome Measure Information:
Title
Live birth rate
Time Frame
At possible delivery (about 40 weeks)
Secondary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
After two weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Tinkanen
Organizational Affiliation
Tampere University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
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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