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Clinical Trials/NCT03115320
NCT03115320
Terminated
Phase 4

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

Tampere University Hospital1 site in 1 country62 target enrollmentJanuary 2017

Overview

Phase
Phase 4
Intervention
Human chorionic gonadotropin
Conditions
Infertility
Sponsor
Tampere University Hospital
Enrollment
62
Locations
1
Primary Endpoint
Live birth rate
Status
Terminated
Last Updated
last year

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
December 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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®

Arms & Interventions

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.

Intervention: Human chorionic gonadotropin

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.

Intervention: Home ovulation test

Outcomes

Primary Outcomes

Live birth rate

Time Frame: At possible delivery (about 40 weeks)

Live birth rate

Secondary Outcomes

  • Ongoing pregnancy rate(After two weeks)

Study Sites (1)

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