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

August 20, 2024 updated by: Tampere University Hospital

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Home ovulation test
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: At possible delivery (about 40 weeks)
Live birth rate
At possible delivery (about 40 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: After two weeks
Ongoing pregnancy rate
After two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Helena Tinkanen, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R16172M
  • 2016-003959-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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