Is there a difference in early pregnancy loss between an endometrium prepared in a natural cycle or by medication prior to transfer of a frozen-thawed embryo?

Natural cycle versus hormone replacement therapy cycle for a frozen-thawed embryo transfer in PGT patients: a randomised trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003156-20-BE

Enrollment

522

Registered

2019-02-26

Start date

2019-03-15

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female infertility

Interventions

Trade Name: Progynova Pharmaceutical Form: Tablet INN or Proposed INN: Progynova CAS Number: 979-32-8 Other descriptive name: ESTRADIOL VALERATE Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 18 and 42 years - 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 522 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Oligo-amenorrhea - Age above 43 years - BMI above 35 - Contraindications for the use of hormonal replacement therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the current study is to compare miscarriage rates (before 8 weeks) between true natural cycle (awaiting spontaneous LH surge) and hormone replacement therapy frozen-warmed embryo transfer cycles in pre-implantation genetic (PGT) testing 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. ;Secondary Objective: not applicable ;Primary end point(s): miscarriage rate before 8 weeks of gestation;Timepoint(s) of evaluation of this end point: at the end of the study, if 522 patients are included	—

Measure

Time frame

Main Objective: The aim of the current study is to compare miscarriage rates (before 8 weeks) between true natural cycle (awaiting spontaneous LH surge) and hormone replacement therapy frozen-warmed embryo transfer cycles in pre-implantation genetic (PGT) testing 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. ;Secondary Objective: not applicable ;Primary end point(s): miscarriage rate before 8 weeks of gestation;Timepoint(s) of evaluation of this end point: at the end of the study, if 522 patients are included

—

Secondary

Measure	Time frame
Secondary end point(s): Miscarriage rate after 8 weeks of gestation Clinical pregnancy rate Ongoing pregnancy rate ;Timepoint(s) of evaluation of this end point: at the end of the study, if 522 patients are included	—

Countries

Belgium

Contacts

Public ContactStudy Nurse

CRG UZ Brussel

003224776648

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026