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

NCT03115320 | Terminated Phase 4 DMC

• 2 other identifiers: R16172M2016-003959-29
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  Live birth rate

  At possible delivery (about 40 weeks)

Secondary Outcomes (1)

• Ongoing pregnancy rate

  After two weeks

Study Arms (2)

Pregnyl (Human chorionic gonadotropin)

EXPERIMENTAL

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

Home ovulation test

OTHER

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

Interventions

Human chorionic gonadotropin DRUG

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

Also known as: Home ovulation test

Pregnyl (Human chorionic gonadotropin)

Home ovulation test OTHER

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

Home ovulation test

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Patient with IVF or ICSI cycle and therefore having frozen-thawed embryos
• Regular menstruation cycle
• Patient's willingness to participate in the study

You may not qualify if:

• \- 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®

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Helena Tinkanen

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: April 14, 2017
• Study Start: January 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 22, 2024

Record last verified: 2020-05

Locations

FI (1)