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

Phase 4

Terminated

• Conditions: Infertility
• Interventions: Other: Home ovulation test; Drug: Human chorionic gonadotropin

• Registration Number: NCT03115320
• Lead Sponsor: Tampere University Hospital

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.

Study Timeline

• Study First Submitted: 2016-11-17
• Study Start: 2017-01
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Primary Completion: 2019-11
• Study Completion: 2019-12
• Status Verified: 2020-05
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home ovulation test	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.
Pregnyl (Human chorionic gonadotropin)	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.

Primary Outcome Measures

Name	Time	Method
Live birth rate	At possible delivery (about 40 weeks)	Live birth rate

Secondary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	After two weeks	Ongoing pregnancy rate

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland