NCT03642665

Brief Summary

This study evaluates clinical pregnancy rates, obstetrical outcome parameters, costs and patient preferences in natural cycle versus artificial cycle frozen embryo transfers (FET).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2024

Enrollment Period

6.1 years

First QC Date

July 17, 2018

Last Update Submit

February 25, 2025

Conditions

Embryo Transfer

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate with fetal heart beat

    Clinical pregnancy rate with fetal heart beat diagnosed by ultrasound no later than the gestational age of 9 weeks

    9 weeks

Secondary Outcomes (12)

  • Biochemical pregnancy rate

    9 weeks

  • Miscarriage rate

    12 weeks

  • Ectopic pregnancy rate

    9 weeks

  • Live birth rate

    41 weeks

  • Multiple pregnancy rate

    9 weeks

  • +7 more secondary outcomes

Study Arms (2)

Natural cycle

EXPERIMENTAL

no medication

Drug: Natural cycle

Artificial cycle

ACTIVE COMPARATOR

Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy. Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Drug: Estradiol ValerateDrug: Micronized progesterone

Interventions

Natural cycleDRUG

no medication

Natural cycle
Estradiol ValerateDRUG

Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Also known as: Artificial cycle
Artificial cycle
Micronized progesteroneDRUG

Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.

Also known as: Artificial cycle
Artificial cycle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \<10mm)
  • Written informed consent

You may not qualify if:

  • 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…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

EstradiolProgesterone

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnenedionesPregnenesPregnanesCorpus Luteum HormonesProgesterone Congeners

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter prospective randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 22, 2018

Study Start

September 25, 2018

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

February 28, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)