What is the best cycle preparation for transferring a thawed embryo: a natural cycle or a cycle with hormonal medication?

Frozen-thawed embryo transfer in a natural versus artificial cycle: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001014-15-BE

Enrollment

554

Registered

2018-04-17

Start date

2018-06-26

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

Patients with subfertility having frozen embryos after in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI)

Interventions

Trade Name: Progynova Pharmaceutical Form: Tablet Trade Name: Utrogestan Pharmaceutical Form: Vaginal capsule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women undergoing FET after a first, second or third fresh IVF/ICSI cycle Single embryo transfer (SET) or Double embryo transfer (DET) Female age between 18-45 year Women having a natural ovulatory cycle (24-35 days) Normal uterine cavity (fundal indentation at the cavity =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Use of donor gametes BMI > or equal to 35 kg / m2 Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate whether endometrial preparation in a natural cycle is superior to an artificially prepared endometrium for patients undergoing Frozen-thawed Embryo Transfer.;Secondary Objective: Evaluate biochemical pregnancy rate, miscarriage rate, ectopic pregnancy rate, live birth rate, multiple pregnancy rate, cycle cancellation rate, endometrial thickness, endometrial pattern, number of center visits to monitor FET cycle, costs per cycle, patient satisfaction;Primary end point(s): Clinical pregnancy rate with fetal heart beat: pregnancy diagnosed by ultrasonographic evidence of at least one fetus with heart beat ;Timepoint(s) of evaluation of this end point: No later than gestational age of 9 weeks	—

Measure

Time frame

Main Objective: to evaluate whether endometrial preparation in a natural cycle is superior to an artificially prepared endometrium for patients undergoing Frozen-thawed Embryo Transfer.;Secondary Objective: Evaluate biochemical pregnancy rate, miscarriage rate, ectopic pregnancy rate, live birth rate, multiple pregnancy rate, cycle cancellation rate, endometrial thickness, endometrial pattern, number of center visits to monitor FET cycle, costs per cycle, patient satisfaction;Primary end point(s): Clinical pregnancy rate with fetal heart beat: pregnancy diagnosed by ultrasonographic evidence of at least one fetus with heart beat ;Timepoint(s) of evaluation of this end point: No later than gestational age of 9 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Biochemical pregnancy rate Miscarriage rate Ectopic pregnancy rate Live birth rate Multiple pregnancy rate Patient Satisfaction Health costs per cycle;Timepoint(s) of evaluation of this end point: Biochemical pregnancy rate: : no later than 6 weeks after the first study visit Miscarriage rate: no later than gestational age of 20 weeks Ectopic pregnancy rate: no later than gestational age of 20 weeks Live birth rate: no later than gestational age of 42 weeks Multiple pregnancy rate: no later than gestational age of 12 weeks Patient Satisfaction: no later than 4 weeks after the first study visit Health costs analysis: at the end of the trial, LSLV	—

Measure

Time frame

Secondary end point(s): Biochemical pregnancy rate Miscarriage rate Ectopic pregnancy rate Live birth rate Multiple pregnancy rate Patient Satisfaction Health costs per cycle;Timepoint(s) of evaluation of this end point: Biochemical pregnancy rate: : no later than 6 weeks after the first study visit Miscarriage rate: no later than gestational age of 20 weeks Ectopic pregnancy rate: no later than gestational age of 20 weeks Live birth rate: no later than gestational age of 42 weeks Multiple pregnancy rate: no later than gestational age of 12 weeks Patient Satisfaction: no later than 4 weeks after the first study visit Health costs analysis: at the end of the trial, LSLV

—

Countries

Belgium

Contacts

Public Contactclinical trial coordinator LUFC

leuven university hospital

myriam.welkenhuysen@leuven.be

Outcome results

None listed

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