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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03115320
• Other study ID #: R16172M
• Secondary ID: 2016-003959-29
• Status: Terminated
• Phase: Phase 4
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: May 2020
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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®

Related Conditions & MeSH terms

• Infertility

Intervention

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

Other:
• Home ovulation test
The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		At possible delivery (about 40 weeks)
Secondary	Ongoing pregnancy rate		After two weeks