Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients

Miscarriage Clinical Trial

Official title:

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976544
• Other study ID #: HRT_NC-FET
• Secondary ID: 2018-003156-20
• Status: Recruiting
• Phase: Phase 4
• Start date: May 25, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: April 2024
• Source: CRG UZ Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 522
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• BMI under 35 kg/m2

• Regular menstrual cycle pattern (i.e. 24-35 days cycle)

• First, second and third ICSI-PGT cycle

• First frozen embryo transfer cycle following a fresh ICSI-PGT attempt

• PGT with trophectoderm biopsy on day 5 of embryonic development

• Signed informed consent

Exclusion Criteria:

• Oligo-amenorrhea

• BMI above 35

• Contraindications for the use of hormonal replacement therapy

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Euploid Embryos
• Frozen Embryo Transfer
• Hormone Replacement Therapy Cycle
• Miscarriage
• Natural Cycle
• Preimplantation Genetic Screening

Intervention

Drug:
• Estradiol Valerate
Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.
• Micronized progesterone
If the endometrium is considered adequately proliferated, micronized progesterone is administered and frozen-thawed blastocyst transfer will take place on the 6th day of supplementation.

Locations

Country	Name	City	State
Belgium	Centre for Reproductive Medicine UZ Brussel	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
CRG UZ Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Miscarriage rate before 8 weeks of gestation	a spontaneous loss of a clinical pregnancy before 8 weeks of gestational age, in which the embryo(s) is/are nonviable and is/are (not) spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG	8 weeks
Secondary	Miscarriage rate after 8 weeks of gestation	a spontaneous loss of a clinical pregnancy after 8 weeks but before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG	22 weeks
Secondary	Clinical pregnancy rate	a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy per initiated embryo transfer cycles	7 weeks
Secondary	Ongoing pregnancy rate	the number of pregnancies after 20 weeks of gestation per initiated embryo transfer cycle	20 weeks