Frozen-thawed Embryo Transfer in a Natural Cycle: hCG Triggering Versus LH Home Test

NCT ID: NCT03115320

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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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 LH surge home test when transferring frozen-thawed embryo in a natural cycle.

Detailed Description

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The aim of this study is to find out the best method for the ovulation triggering. We study the live birth rates in the both groups.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Human chorionic gonadotropin

Intervention Type DRUG

Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.

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.

Group Type OTHER

Home ovulation test

Intervention Type OTHER

The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.

Interventions

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Human chorionic gonadotropin

Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.

Intervention Type DRUG

Home ovulation test

The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.

Intervention Type OTHER

Other Intervention Names

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Home ovulation test

Eligibility Criteria

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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®
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helena Tinkanen

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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2016-003959-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

R16172M

Identifier Type: -

Identifier Source: org_study_id

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